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POLITICALLY CORRECTED SCIENCE The Early Negotiation of U.S. Agricultural Biotechnology

Policy

by Mary Ellen Jones Dissertation submitted to the Faculty of Virginia Polytechnic Institute and State University in partial fulfillment of the requirements for the degree of DOCTOR OF PHILOSOPHY in SCIENCE AND TECHNOLOGY STUDIES Approved By: __________________ Doris T. Zallen, Chair __________________ __________________ Richard M. Burian Cornelia B. Flora __________________ Richard F. Hirsh

__________________ Sue A. Tolin November 19, 1999 Blacksburg, Virginia

Keywords: rDNA, recombinant DNA, agriculture, genetic engineering, science and politics, Jeremy Rifkin, Cloneheads, Reagan Administration, periodicity of technological controversy, world view, and science policy. Copyright 1999, Mary Ellen Jones

ii

POLITICALLY CORRECTED SCIENCE The Early Negotiation of U.S. Agricultural Biotechnology

Policy

by Mary Ellen Jones

ABSTRACT This social history of science policy development emphasizes the impact on the agricultural community of federal policies regarding release of recombinant DNA (rDNA) organisms into the environment. The history also demonstrates that the U.S. Coordinated Framework for Biotechnology Regulation (1986) is based principally in political criteria, not solidly based in science as its proponents claimed.

The power

struggle among policy negotiators with incompatible belief systems resulted in a political correction of biotechnology.

I also demonstrate

that episodes in the rDNA controversy occur in repetitive and periodic p a t t e rn s. During the 1980s, the first rDNA microbial pesticide, Ice-Minus, struggled through a policy gauntlet of federal agency approval processes, a Congressional hearing, and many legal actions before it was finally released into the environment.

At the height of the controversy

(1984-1986), the Reagan Administration would admit no new laws or regulations to slow the development of technologies or hinder American

iii international competitiveness.

At the same time, Jeremy Rifkin, a

radical activist representing a green world view, used the controversy to agitate for social and economic reform.

Meanwhile, a group of

Congressional aides who called themselves the ÒCloneheadsÓ used the debate to fight for more public participation in the science policymaking process. Conflicting perspectives regarding biotechnology originated, not in level of understanding of the science involved, but in personal perspectives that were outwardly expressed as political group affiliations.

The direction of federal biotechnology policy was

influenced most successfully by politically best-positioned individuals (what I call a Òhierarchy effectÓ) who based decisions on how biotechnology harmonized with their pre-existing beliefs.

The success

of their actions also depended on timing. Historical events during the rDNA controversy followed the same periodic pattern--gestation, threshold, crisis/conflict, and quasiquiescence--through two consecutive eras--the Containment Era (1970s) and the Release Era (1980s).

These periods are modeled after

FletcherÕs stages through which ethical issues evolve (1990).

However,

an agricultural perspective on the debate reveals that such stages also occur in finer detail on repeating, overlapping, and multi-level scales. Knowledge of this periodicity may be useful in predicting features of future episodes of the rDNA controversy.

iv

DEDICATION

This work is fondly dedicated to the memory of

LORETTA E. deDUFOUR,

and her insatiable curiosity.

v

ACKNOWLEDGMENTS When a project as time consuming as this is finally finished, one can be sure that there will be many more people to thank than room to list all the names.

I could not have done this without the help of a

multitude of people--from the many interview subjects who are listed in Appendix A to a great many librarians in Virginia and in Washington, DC.

However, there are a few people who created for me such a vital

support system that it is appropriate to acknowledge them here. Most doctoral students have one major professor and four committee members who read and make comments on the dissertation.

Instead, I

have been blessed with four major professors and one patron saint, Doris Zallen, without whose leadership and influence I would surely have lost my way.

Each and every individual on my committee (Dick

Burian, Neal Flora, Richard Hirsh, and Sue Tolin) has far exceeded what is normally expected of a non-chair committee advisor, in both moral support and academic assistance.

I thank them all for believing in me,

even when I did not, for sticking by me for so many years, and for their friendship. I also wish to thank Congressman Rick Boucher (D-VA-9th) for the opportunity to serve in his Washington office as a Graduate Congressional Fellow for the fall 1997 semester, and for the rewarding political education I experienced as a result.

I am grateful to the

Graduate School of Virginia Tech for supporting me in Washington during that fellowship.

I also thank the University for financial support

vi during my 1996 Virginia GovernorÕs Fellowship in Richmond.

These two

fellowships were invaluable in providing ideas, contacts, and other research resources for this dissertation. Sue Tolin deserves extra recognition for graciously opening her personal biotech policy archive to me, without which this project would not have been possible.

I can never thank Brenda Shirley of the Biology

Department enough for providing me with an opportunity to work in her molecular biology laboratory, which gave me both a fully equipped office retreat on campus and a feeling of connectedness with the study of life sciences I left behind when I transferred to the Center for Study of Science in Society. Jean Miller, my fellow student, unselfishly loaned me her own sanity whenever I lost my own, and kept us caught up on the ÒfarmÓ work so I could get back to writing.

Thank you, Jean, for being a true friend.

Finally, for putting up with me through all of this, George, YOU ARE THE SWEETIE !!

vii

ADVICE ON ACRONYMS Although acronyms will be defined the first time they are used, the list below is offered as a reference. The underlined acronyms will be used so frequently that the reader may wish to take note of them now. AGS = Advanced Genetic Sciences, a private biotechnology firm. APHIS = The Animal and Plant Health Inspection Service, the main regulatory branch of USDA with respect to rDNA. A-RAC = USDAÕs Agriculture Recombinant DNA Advisory Committee. ARPAC = Agricultural Research Policy Advisory Committee. Agricultural rDNA council.

An early

ARS = Agricultural Research Service, USDAÕs in-house research agency. BSCC = Biotechnology Science Coordinating Committee. CRG = Coalition/Committee/Council for Responsible Genetics. Organization changed names several times.)

(This

CSRS = USDA Cooperative State Research Service that coordinates research activities in the Land Grant System. E.O. = Executive Order of the president of the United States. EPA = Environmental Protection Agency. FDA = Food and Drug Administration. FIFRA = Federal Insecticide, Fungicide, and Rodenticide Act administered by EPA. FET = Foundation on Economic Trends.

Jeremy Rifkin, President.

FR = The Federal Register, a daily publication of announcements from U.S. federal agencies.

viii GAO = (Congressional) General Accounting Office. IRMC = Interagency Risk Management Council, led by EPA. JCRC = Joint Council Recombinant DNA Committee, an early Agricultural rDNA council. NASULGC = National Association of State Universities and Land Grant Colleges, a Washington lobby group for state higher education. NBIAP = National Biological Impact Assessment Program. NEPA = National Environmental Policy Act of 1969 (42.USC.¤4321). NIH = The National Institutes of Health. NSF = National Science Foundation. OECD = Organisation for Economic Cooperation & Development, Paris, FR. OMB = White House Office of Management and Budget. ORDA = The NIH Office of Recombinant DNA Activities. OPTS = EPAÕs Office of Pesticides and Toxic Substances, which administers FIFRA and TSCA. OSTP = The White House Office of Science and Technology Policy. OTA = (Congressional) Office of Technology Assessment. RAC = The NIH Recombinant DNA Advisory Committee. SEA = Science and Education Administration, a division at USDA that administered CSRS and ARS. (Also called S&E). TSCA = Toxic Substances Control Act administered by EPA. USDA = United States Department of Agriculture.

ix

TABLE OF CONTENTS ABSTRACT DEDICATION ACKNOWLEDGMENTS ADVICE ON ACRONYMS TABLE OF CONTENTS CHAPTER ONE: INTRODUCTION D ISCORD IN DNA S CIENCE B ASED P OLICY ? W ORLD VIEW S PEEDING SCIENCE S IGNIFICANCE OF PROJECT SCOPE METHODOLOGY S UMMARY OF C HAPTERS

II IV V VII IX 1 1 3 5 8 9 14 15 17

PART I - BACKGROUND AND CONTEXT

20

CHAPTER TWO: AGRICULTURE AND SOCIETY BEFORE BIOTECH

21

INTRODUCTION T HE B EGINNINGS OF A GRICULTURAL B IOTECHNOLOGY T HE G OLDEN A GE OF A MERICAN S CIENCE IN S OCIETY T HE R ADICAL Ô60 S AND T HE E ROSION OF P UBLIC T RUST IN S CIENCE S UMMARY

21 21 29 32 39

CHAPTER THREE: HIGHLIGHTS OF THE EARLY BIOTECH DEBATE: THE ERA OF CONTAINMENT 40 INTRODUCTION E ARLIEST C ONGRESSIONAL D ISCUSSION A SILOMAR I AND THE ÒSINGER-SOLL L ETTERÓ THE ÒBERG LETTERÓ AND R ESEARCH M ORATORIUM A SILOMAR II NIH ÒGUIDELINESÓ INTEGRITY B ACKFIRES S CIENTISTS D IVIDED R ESOLUTION ILLUSION? S UMMARY

40 41 43 46 47 48 50 51 56 61

PART II - LETTING THE GENIE OUT OF THE BOTTLE

63

CHAPTER FOUR: GESTATION OF A NEW ERA IN THE RDNA DEBATE: 1977-1981 64 INTRODUCTION

64

x R ISKY B USINESS P ROHIBITIONS AND O BSTACLES T HAT H INDERED A GRICULTURAL B IOTECHNOLOGY A GRICULTURAL A CADEMIA AND T HE L AND G RANT S YSTEM INITIAL USDA INVOLVEMENT WITH RDNA POLICY C HALLENGING PROHIBITION S UMMARY CHAPTER FIVE: REGULATORY SCHIZOPHRENIA INTRODUCTION R EGULATORY SCHIZOPHRENIA T HE RAC IN THE W RINGER S UMMARY

64 72 77 80 86 99 100 100 102 105 116

CHAPTER SIX: THRESHOLD OF THE RELEASE ERA: FROM THEORY TO REALITY 118 INTRODUCTION DIAMOND V. CHAKRABARTY S PEARHEADS G ENETIC G OLD R USH A LETTER FROM T HREE G ENERAL SECRETARIES S PLICING L IFE R EQUESTS TO R ELEASE RDNA ORGANISMS INTO THE E NVIRONMENT NIH AND USDA COLLABORATION S UMMARY

118 118 121 123 125 131 141

CHAPTER SEVEN: WASHINGTON CIRCUS: 1983

144

INTRODUCTION H OUSE D EMOCRATS AND RDNA C RITICS R ALLY A GAINST RDNA RACÕ S B IGGEST B ACKER - USDA EPA MAKES A P LAY FOR O VERSIGHT OF RDNA R EACTIONS TO EPAÕ S M OVE F ORWARD R IFKIN R ATTLES THE RAC T HE T ALBOT B OUNDARIES P ROPOSAL R ESPONSES TO THE B OUNDARIES P ROPOSAL T HE T WILIGHT OF A P ARADIGM S UMMARY

144 144 159 161 164 166 170 175 176 179 181

PART III - WHO WILL CONTROL THE GENIE?

185

CHAPTER EIGHT: 1984 - A HOUSE DIVIDED

186

INTRODUCTION G ESTATION : ÒGUIDELINES O NLY Ó VIEWPOINT F ALTERS - WINTER 1984 T HRESHOLD : RELEASE ISSUE R EALITY C HECK - SPRING 1984 C RISIS /C ONFLICT : DIVISION AND C HANGE AT USDA - SUMMER 1984 Q UASI -QUIESCENCE : GIVING IN TO R EAGAN - AUTUMN 1984 S UMMARY

186 187 196 203 213 221

CHAPTER NINE: THE REAGAN ADMINISTRATION AND THE COORDINATION OF FEDERAL OVERSIGHT FOR BIOTECHNOLOGY 225 INTRODUCTION T HE R EAGAN Y EARS C OORDINATING THE FEDERAL FRAMEWORK 1985: IRONING O UT THE D IFFERENCES

225 226 241 251

xi T HE C OORDINATED F RAMEWORK OF 1986 C ONCURRENT INTERNATIONAL A FFAIRS E FFECTS OF C OORDINATED F RAMEWORK S UMMARY CHAPTER TEN: JEREMY RIFKIN - A GREENER WORLD VIEW INTRODUCTION R IFKINÕS W ORLD V IEW T HE C OMMITTEE FOR R ESPONSIBLE G ENETICS - ANOTHER G REEN P ERSPECTIVE ISOLATING B IG B USINESS AS V ILLAIN A TTACKING THE A DMINISTRATION AS C ORPORATE A CCOMPLICE F ROSTBAN F IELD D A Y S UMMARY

259 266 267 269 272 272 273 280 282 283 289 290

CHAPTER 11: DEMOCRATS AND DNA: CLONEHEADS TRY TO FIX THE FEDERAL FRAMEWORK 292 INTRODUCTION C APITOL H ILLOCRATS L EGISLATING SCIENCE THE CLONEHEADS U NDERMINING THE U NCOORDINATED F RAMEWORK T HE O MNIBUS B IOTECHNOLOGY A CT INDICATORS OF Q UIESCENCE S UMMARY

292 293 295 298 308 317 324 326

PART IV LEARNING FROM THE GENIE

329

CHAPTER TWELVE: PATTERNS IN POLICY MAKING

330

POLITICALLY C ORRECTED SCIENCE T HE RDNA POLICY D EBATE IS P OLITICAL T HE RDNA POLICY D EBATE D ERIVES F ROM W ORLD V IEW T HE RDNA POLICY D EBATE IS P ERIODIC FINAL THOUGHTS

330 331 336 341 347

PUBLISHED REFERENCES

350

APPENDICES

377

VITA

393

CHAPTER ONE: INTRODUCTION

Discord in DNA The discord at the interface between recombinant DNA (rDNA) technology and the society in which it is developing has been called ÒThe Biotechnology DebateÓ or ÒThe rDNA Controversy.Ó The controversy, which began in the early 1970s, ostensibly centered on risks to the safety of humans and the integrity of the environment posed by moving pieces of heritable molecules either within species or between and among species. However, the debate also represents, among other things, an ongoing saga of struggle between the benefits of academic freedom and entrepreneurial spirit on the one hand and the rights of individuals to make informed decisions for themselves about which risks should be taken on the other.

Although the most visible disputes have tended to

focus on safety issues, the debate was, and is, about the fundamental issue of controlling life.

It is a social debate about who should have

access to that control, who benefits from it and who accepts whatever risks there may be.

Most importantly, it is a debate about choices and

deciding w h o should decide. on science as on politics.

Such decisions can be based not so much

Even a preference for a particular definition of

the word ÔbiotechnologyÕ indicates differences in personal perspectives and efforts to promote vested interests in this debate.1 1

In this dissertation, I will use the terms ÒrDNA technology,Ó Òbiotechnology,Ó and Ògenetic engineeringÓ interchangeably. Although I realize that there are technical differences, to distinguish among them here would serve no useful

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Politically Corrected Science

2

In the 1970s and 1980s, two overlapping phases of the rDNA controversy shook Capitol Hill, and aftershocks echoed in laboratories throughout the country.

These two phases of the controversy are what

I shall call the Era of Containment (1970s) and the Era of Release (1980s).

As rDNA technology moved from basic to applied research,

from knowledge to products, and from indoor to outdoor experimentation, the debate about regulating rDNA--far from over-rose to a new level in the 1980s.

Policy analysts today still dispute the

appropriateness of rDNA regulatory decisions made during those decades.2 A subset of the rDNA controversy, which was prominent during the 1980s, was the matter of overseeing the release of rDNA into the environment, an activity vital to the ability of agriculture to benefit from the new technology.

While revealing some of the historical details

of the agricultural communityÕs role in developing this aspect of U.S. biotechnology policy, I will demonstrate that the second era of the debate (the Release Era) followed the same periodic pattern as the first (the Containment Era).

If a repetitive periodicity to the controversy can

be established, it might be used to predict features of the current Global Era of the rDNA controversy.3

purpose. In fact, the disagreement over basic definitions was the first signal that there was something other than science playing a role in the formation of biotechnology policy. 2 See recent publications such as Miller, Henry I., (1997). Policy Controversy in Biotechnology: An Insider's View. Austin, R.G.Landes Co. and Ho, Mae-Wan, (1998). Genetic Engineering: Dream or Nightmare? Bath, UK, Gateway Books. Miller is a former high ranking Food and Drug Administration official. Ho is from the Open University in the UK. 3 The concept of technology controversy embedded in a political cycle is explored by Jasper, James M., (1988). ÒThe Political Life Cycle of Technological Controversies.Ó Social Forces. v. 67 (2) (December) pp. 357-377.

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Science Based Policy? Is science policy based on science alone?

ÒScience-based policyÓ

implies that the policy is objective and not interest based.

In reality,

science policy involves not only science, it involves the social art of negotiation.

It is either naive or disingenuous of any policy maker to

claim that only science influences science policy decisions, as we can learn from the larger rDNA debate and the present study.

As one

federal official observed, ÒBiotechnology regulatory policy requires [looking] beyond the technical research alternatives [to an understanding of] human, institutional, and political processes.Ó4 The need for biotechnology policy became apparent in the early 1970s when scientists themselves became so concerned about the potential hazards of working with rDNA in their research laboratories that a voluntary moratorium on research was called until safety guidelines could be formulated.

By calling public attention to safety

considerations in their own laboratories, scientists caused a flurry of public concern throughout the 1970s about the pursuit of recombinant DNA research.5

The anxiety diminished somewhat toward the end of

that decade after the National Institutes of Health Recombinant DNA Advisory Committee (RAC) had put into place Guidelines for Research Involving Recombinant DNA Molecules (hereafter simply ÒGuidelinesÓ) to confine the research to facilities designed to prevent the escape of rDNA organisms..6 4

John R. Wood, Senior Staff Officer, Plant Protection and Quarantine, APHIS, USDA, in a December 26, 1984, memo to James Glosser, Assistant to the Administrator, APHIS, USDA, APHIS. MEJ personal archive; File: Igb. 5 Bennett, William and Joel Gurin, (1977). ÒScience that Frightens Scientists: The debate over DNA.Ó The Atlantic Monthly. v. 239 (February) pp. 43-62. 6 On October 7, 1974, the National Institutes of Health (NIH) established the

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4

However, in the 1980s when rDNA research and products were ready to move from the laboratory to the testing field and the marketplace, the controversy reemerged with renewed vigor at a new level. pause in the conflict was merely for a change in the scenery.

Any The same

actors were there, still clashing in the same roles, but on a newly set stage.

The bulk of my work focuses on the second era of this

controversy, from the beginnings of the agricultural communityÕs involvement, through the apparent quiescence after the establishment of the Federal Coordinated Framework for Regulation of Biotechnology in 1986. In this dissertation, I will examine the social and political events that influenced the course of policy development for a novel technology in its second stage of controversy.

I disclose evidence that there were

major factors other than science--social, political, and economic factors-that played a role in the path taken by the U.S. Government in developing federal rDNA policy during this period.

Thus, my account of

the development of rDNA policy is more about political strategy, than it is about science. Both fear and technological knowledge can become powerful political tools in formulating regulatory control of science.

Conversely,

regulatory oversight can have the effect of altering and correcting the path of research and development of technology.

While exploiting both

the fear of and the promises of rDNA technology as political bargaining Recombinant DNA Molecule Program Advisory Committee, later renamed the Recombinant DNA Advisory Committee, or ÒRACÓ (39 FR 39306). See also p.349 in Krimsky, Sheldon, (1982). Genetic Alchemy: The Social History of the Recombinant DNA Controversy. Cambridge, MA, MIT Press. The RAC developed research guidelines for containment of rDNA organisms, the first of which were released on July 7, 1976 (41 FR 27902). These Guidelines were repeatedly revised

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5

chips, interested players negotiated the regulation of a speeding science while leaving a perplexed general public in their wake.

In the process,

the path of biotechnology became Òpolitically corrected.Ó

World View The term Òworld viewÓ refers to all those relevant beliefs and understandings that an individual already possesses against which new knowledge is compared before accepting it as true.

Fundamental beliefs

about the world have a profound influence on the choices individuals make throughout life.

These beliefs are learned through personal

experiences and interactions with families, cultural communities, churches, schools, workplaces, and other social institutions. is a personal and constantly evolving attribute.

World view

Thus, it is difficult to

measure. The extent to which I am utilizing world view theory is only to base my supposition that personal experiences and values influence decision making.

The collective world views or personal values of a group of

like-minded people constitutes an ÔideologyÕ according to which they make choices about such matters as how they should live, govern themselves, and consider the earthÕs natural resources.

People who

subscribe to a philosophical ideology, or a shared view of goals for society, frequently, though not always, also share opinions on the best means of attaining those goals.

Preference for a specific means to a

social end can be outwardly expressed through affiliation with certain political parties or support of particular policy approaches.

Given a

support system for beliefs, it is easier to hold on to them than to let go. and relaxed as familiarity with rDNA grew.

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6

Sir Francis Bacon warned that human beings who are indoctrinated into a certain way of thinking find it very difficult to let go of that internalized framework.7

Centuries later, Thomas Kuhn described the

same phenomenon at work in his classic book, The Structure of Scientific Revolutions.8 From my own experience in attending scientific conferences during the late 1980s and early 1990s, rarely did the topic of anti-technology activism come up without an assertion that critics of the new biotechnologies must harbor an irrational fear of the unknown, and that more and better science education was the antidote.

The underlying

assumption was that if only ÒtheyÓ had ÒmyÓ information, ÒtheyÓ would see things ÒmyÓ way.

This attitude fails to consider that ÒmyÓ

information would be filtered through what ÒtheyÓ already know or believe.

An explanation from world view theory would be Òthat in some

cases, it is not that [people] fail to understand what is being taught ... they simply do not believe....Ó9

An excellent case study for examining

the role of world view in science policy controversy is the antibiotechnology campaign of Jeremy Rifkin, the most outspoken opponent of rDNA, which will be addressed in Chapter Ten. The presence of knowledgeable scientists and lay people on all sides of the rDNA controversy provides evidence that something other than an understanding of the science behind the rDNA has influenced 7

Jones, Richard Foster, ed., (1937). ÒAphorisms concerning the Interpretation of Nature and the Kingdom of ManÓ in Essays, Advancement of Learning, New Atlantis, and Other Pieces by Sir Francis Bacon. New York. Odyssey Press. p. 491. 8 Kuhn, Thomas S., (1962). The Structure of Scientific Revolutions. Chicago, University of Chicago Press. 9 Cobern, William W., (1989). ÒWorld View Theory and Science Education Research: Fundamental Epistemological Structure as a Critical Factor in Science Learning and Attitude Development.Ó. ERIC NO: ED304345. Accessed June 17, 1998.

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individual acceptance of the technology.

7

Because of the effect of world

view on public decision making, the oft promoted focus on science education as the primary means of preparing the public for acceptance of the products of rDNA (as advocated by the Biotechnology Industry Organization)1 0 may not work.

Although a basic understanding of the

science behind rDNA may facilitate public decision making about rDNA products, understanding is insufficient to guarantee acceptance.

For

example, two studies have suggested that the m o r e people know about one particular technology--human embryo research--the less likely they may be to accept it as appropriate.1 1 World view, ideology, and politics begin to play a larger role in policy making when decisions must be made with incomplete information or scientific uncertainty. trusted leaders.

Like-minded people will rally behind their

The same scientific data will be cited, but will be

interpreted differently by different groups, because, as Francis Bacon observed, ÒThe human understanding when it has once adopted an opinion ... draws all things else to support and agree with it. ... For what a man had rather were true he more readily believes.... 1 2

10

Biotechnology Industry Organization, (1993). Biotechnology Industry Organization Grassroot Manual. BIO. Washington, DC. November. Report. 11 Evans, Geoffrey and John Durant, (1995). ÒThe relationship between knowledge and attitudes in the public understanding of science in Britain.Ó P u b l i c Understanding of Science. v. 4 (1) (January) pp. 57-74.; Also, Mulkay, Michael, (1995). ÒPolitical parties, parliamentary lobbies, and embryo research.Ó P u b l i c Understanding of Science. v. 4 (1) (January) pp. 31-55. 12 Jones, Richard Foster, ed., (1937). ÒAphorisms concerning the Interpretation of Nature and the Kingdom of ManÓ in Essays, Advancement of Learning, New Atlantis, and Other Pieces by Sir Francis Bacon. New York. Odyssey Press. p. 491. See Aphorism XLVI at p.281 and Aphorism XLIX at p. 283.

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The negotiation of federal biotechnology policy during the 1980s is best described as an attempt by various interest groups with competing world views to make this new technology Òpolitically correctÓ--each according to different political perspectives.

This concept will be

explored in greater detail in my concluding chapter.

Speeding science As the 20th Century draws to a close, the science of biotechnology continues to advance at an incredible pace.

Anything as fast moving

and complex as the new biotechnologies is intimidating to those who must consider all of its social implications.

Policy makers face the

prospect of regulatory obsolescence before regulations can even be developed.

Promises bring costs.

While trying to calculate those costs,

some critics have reasoned that it might be preferable to mandate universal stop signs for the entire process rather than to attempt (often futilely) to negotiate appropriate speed limits for each product application.

This argument is especially relevant when one considers

that the speeding vehicle may have gone past before the costs and appropriate speed limits can be calculated. Concerns have persisted for over thirty years that biotechnology is far outstripping societyÕs ability to keep up with the ethical challenges it presents.

It took the U.S. the better part of a decade to develop a policy

that would allow the agricultural community to conduct outdoor rDNA research and to develop rDNA products.

Ironically, although

international competitiveness was given the highest consideration in the formation of U.S. policy for agricultural biotechnology by the two Reagan administrations, American rDNA agricultural products are

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increasingly being shunned in Europe today--especially in countries which have a strong Green party political presence.1 3

Significance of project The social history of the first decade of the Biotechnology Debate (1973-1982), has been admirably documented by other scholars.1 4 However, similar treatment for the second stage of the debate (19821990), when rDNA went outside the laboratories and raised the controversy to a new level, has been inadequate.

Science studies

scholar Susan Wright went so far as to claim that by 1982 the rDNA debate was essentially over.1 5 I wholeheartedly disagree. issue by the early 1980s.

The rDNA controversy was not a dead

It was not until the late 1970s that there

were even any products of rDNA research ready for testing. Agricultural applications required field research and testing of living organisms normally grown in an outdoor environment.

By 1988,

according to Study Director, L. Val Giddings, an investigation of rDNA field testing by the U.S. Congressional Office of Technology Assessment 13

See, for example, Claude, Patrice, (1999). Ò'Charles le Bio' Contre ' Tony le Le Monde. Paris. June 3, p. 1.; Kilman, Scott and Helene Cooper, Transgenique'.Ó (1999). ÒMonsanto Falls Flat Trying to Sell Europe on Bioengineered Food.Ó Wall Street Journal, Eastern Edition. New York. May 11, pp. A1, A 10.; Associated Press, (1999). ÒGenetic Engineering is Focus of Summit.Ó Sarasota Herald Tribune. Sarasota, FL. February 20, 14 Watson, James D. and John Tooze, (1981). The DNA Story: A Documentary History of Gene Cloning. San Francisco, W. H. Freeman and Company.; Krimsky, Sheldon, (1982). Genetic Alchemy: The Social History of the Recombinant DNA Controversy. Cambridge, MA, MIT Press.; Wright, Susan, (1994). Molecular Politics: Developing American and British Policy for Genetic Engineering, 1972-1982. Chicago, University of Chicago Press. 15 Wright, Susan, (1994). Molecular Politics: Developing American and British Policy for Genetic Engineering, 1972-1982. Chicago, University of Chicago Press. Wright focused on biomedical applications of genetic engineering, which were several years ahead of agricultural research.

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was, Òthe most controversial thing that OTA had seen outside of the national defense arena.Ó1 6

The controversy over release of rDNA into

the environment was clearly politically charged in its own right. Sheldon KrimskyÕs Biotechnics & Society follows the debate into the 1980s, but focuses broadly on industry, patenting, ecology, and human genetic engineering, not on agricultural.1 7

Joel Schor published a

summary of the development of biotechnology relevant to agriculture for the U.S. Department of Agriculture (USDA) Economic Research Service, but while it served its intended purpose of documenting dates and events, it provided no social analysis.1 8

Likewise, Tolin and Vidaver

have presented an account of agricultural rDNA concerns from the perspective of academe, but did not attempt to examine the political underpinnings of the controversy.1 9

This is the first detailed social

documentary of U.S. rDNA policy development in the 1980s that has emphasized agricultural issues.

As such it provides an explanation for

how the U.S. arrived at the oversight policy contained in the

16

Interview with Val Giddings, Ph.D. Study Director for U.S. Congress, OTA, "New Developments in Biotechnology: Field Testing Engineered Organisms: Genetic and Ecological Issues", formerly with OTA; presently with Biotechnology Industry Organization. Washington, DC (November 12, 1997). 17 Krimsky, Sheldon, (1991). Biotechnics and Society: The Rise of Industrial G e n e t i c s. New York, Praeger. A single chapter about the first field test of recombinant bacteria for the purpose of crop protection follows an Environmental Protection Agency perspective. See Chapter 7, ÒControlling Frost With Bacteria: The First Field Test.Ó Sheldon Krimsky is a social historian and Professor of Urban and Environmental Policy at Tufts University. He was a member of the NIH RAC from 1978-1981, and has published extensively on the rDNA debate. (Sheldon Krimsky Homepage ). 18 Schor, Joel, (1994). The Evolution and Development of Biotechnology: A Revolutionary Force in American Agriculture. Washington, DC, US Department of Agriculture, Economic Research Service, A&RE Division. 19 Tolin, Sue A. and Anne K. Vidaver, (1989). ÒGuidelines and Regulations for Research with Genetically Modified Organisms: A View From Academe.Ó A n n u a l Review Phytopathology. v. 27 pp. 551-81.

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Coordinated Framework for Regulation of Biotechnology.

11 Thus, this

dissertation will contribute to the knowledge base in science and technology studies. In addition, if understanding a problem is the first step toward dealing with it, then understanding the underpinnings of opposition to a technology is the first step toward confronting that opposition, or deciding whether it should be confronted.

Therefore, scientists should

welcome a study of the criticism and opposition to their research just as they would welcome peer review of its technical soundness. Clarification of the causes, beyond safety issues, for concern about using rDNA techniques and a reconstruction of the controversy surrounding the release of rDNA into the environment should also interest the biotechnology industry, environmentalists, patent attorneys, social theorists, government regulatory agencies, funding agencies, and policy makers who must make informed decisions relating to rDNA. I will also demonstrate a periodicity to the rDNA controversy, which may be useful to future policy makers.

Specifically, the demonstration

that the debate of the Release Era repeats the pattern of debate in the Containment Era may help analysts to anticipate features of the now emerging world-wide debate over uses of agricultural products containing rDNA.

Given that many of the same actors and scenarios

from Acts I and II are still present, it is reasonable to assume that Act III may unfold similarly.

Although it is necessary to be sensitive to the

attendant risks of using historical data to predict the future when so many variables are involved, this approach can help to make clear the assumptions and goals of participants by comparing compatible aspects of the debate from different time periods.

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12

My periodicity thesis is based mainly on the works of Fletcher and on Jasper.

Using the human gene therapy controversy as a case study,

Fletcher observed that different events (and issues, or discussions) go through four stages: threshold, open conflict, extended debate, and adaptation.2 0

His analysis, which spans the years 1967 through 1990,

clearly shows the importance of an ethical component, in addition to scientific factors, in the human gene therapy debate.

I will show that

FletcherÕs stages on the relatively large time scale that he presents for human gene therapy, pertain also to multiple, smaller time scales for other subsets of the rDNA debate.

The similarities between FletcherÕs

study and my own, in topic area, time periods, and characterization of the debate, strongly suggests that scientific data were not the only driving forces at work. Jasper blends the concept of personal values with periodicity (political life cycle) in his study of the nuclear power controversy and concludes that, Ò[s]ustained, visible controversy over technologies may reflect serious debate over political and social goals rather than irrational fears stirred by the mass media.Ó2 1

Jasper also determined

that world view explains why individuals took the sides they did in the nuclear power controversy.

He divides the political cycle into a pre-

political period in which people have faith in expert opinion, a politicization period sparked by the mediaÕs highlighting of disagreements between experts, and a conflict period when basic values and beliefs shape attitudes. 20

After the government takes actions, the

Fletcher, John C., (1990). ÒEvolution of Ethical Debate about Human Gene Therapy.Ó Human Gene Therapy. v. 1 (1) (Spring) pp. 55-68. 21 Jasper, James M., (1988). ÒThe Political Life Cycle of Technological Controversies.Ó Social Forces. v. 67 (2) (December) pp. 357-377. See p.357.

Chapter 1


13

issue depoliticizes and the public accepts the new policies rather than returning to the pre-political trust of experts.2 2 The terms that I have chosen to represent periods in the Containment and Release Eras of the rDNA debate are Ògestation,Ó Òthreshold,Ó Òcrisis/conflict,Ó and Òquasi-quiescence.Ó

I prefer to label as

Òquasi-quiescentÓ the adaptive periods which both Fletcher and Jasper describe at the ends of each cycle, because although the debate may have lost the attention of the general public, the inner circle of participants in the debate has not lost interest.2 3

Quasi-quiescence may

in actuality harbor a gestation period for the next era in the political life cycle of the rDNA debate. Finally, much of the history of the USDAÕs Recombinant DNA Advisory Committee exists only in private archives, because the documents and proceedings of the intra-agency panel were not required to be placed in the public record.

With institutional memory dwindling,

new USDA personnel are currently facing similar rDNA policy crises without the benefit of readily available historical exemplars to guide t h e m .2 4

I hope that this dissertation and future works based on my

research will fill that void and provide a practical application for my efforts.

22

Ibid. Jasper, James M., (1988). ÒThe Political Life Cycle of Technological Controversies.Ó Social Forces. v. 67 (2) (December) pp. 357-377. See p.361. 23 A reduction in media attention to rDNA issues in the early 1980s is described in Goodell, Rae, (1986). ÒHow to Kill a Controversy: The Case of Recombinant DNAÓ in Scientists and Journalists: Reporting Science as News. S. M. Friedman, S. Dunwoody and C. L. Rogers, Eds. New York. The Free Press/Macmillan. pp. 170-181. Indicators of quasi-quiescence in the 1980s will be described in Chapter Eleven. 24 Shirley Ingebritsen, Senior Regulatory Specialist with the APHIS, USDA biotechnology program, personal communication, 1999.

Chapter 1


14

Scope The impetus for my research took the form of an assertion by Suzanne Huttner, Director of the University of California Systemwide Biotechnology Research and Education Program, who stated that activists are not Òdriven by misunderstandings of scientific issues of risk.

They are more likely fueled by an historical disaffection for

industrial agriculture.Ó2 5

Huttner maintained that these social issues

should be exposed and discussed separately.

Suspecting that the rDNA

debate may be a reflection of underlying Òsocial prejudices ... veiled by a contrived scientific ÔcontroversyÕ,Ó Huttner presented an interesting explanation but declined to develop it.2 6

This dissertation examines her

speculation about the underpinnings of opposition to agricultural biotechnology. Rather than attempting to address all of the contentious issues of the rDNA Release Era, this dissertation will focus on those events which best bring to light the socio-political underpinnings of the debate as it related to agricultural interests.

Thus, I present a series of

interconnected episodes, rather than a complete, detailed documentary, of important events depicting the agricultural communityÕs involvement in the rDNA release debate and the formation of U.S. biotechnology policy.

25

Incidents were selected not only for historical significance, but

Huttner, Susanne, (1995). ÒGovernment, Researchers, and Activists: The Critical Public Policy InterfaceÓ in Legal, Economic, and Ethical Dimensions, Volume 12. D. Brauer, Ed. New York. VCH (J. Wiley and Sons). pp. 460-493. See p.480 26 Ibid. at p.483 Huttner, Susanne, (1995). ÒGovernment, Researchers, and Activists: The Critical Public Policy InterfaceÓ in Legal, Economic, and Ethical Dimensions, Volume 12. D. Brauer, Ed. New York. VCH (J. Wiley and Sons). pp. 460493.

Chapter 1


15

for their relevance to the theory that science policy is not wholly science-based, but a politics-based social art. Although concerns about human gene therapy and clinical testing of rDNA medical products evolved during the same time period, human medical applications will not be considered here because, for the most part, medical applications involve purified protein products, not the release of live rDNA organisms into the environment.

(Two exceptions

are the use of viral vectors in gene therapy and live rDNA vaccines.) Neither will this work cover the Human Genome Project (HGP) because there are other extensive works available on these topics.2 7

Although

the right to patent living organisms has been hotly debated since the 1970s, patenting issues, except for one especially relevant event (see Chapter Six), are beyond the scope of this project.

Methodology Literature, government documents, internal memos available only in personal archives, and various items of public record have been supplemented by interviews with selected participants in the debate. My methodology been influenced by the approach of Adrian Desmond 27

For example see U.S. Congress, House of Representatives, Committee on Science and Technology, Subcommittee on Science Research and Technology, (1980). Genetic Engineering, Human Genetics, and Cell Biology: Evolution of Technological Issues. U.S. Government Printing Office. Washington, DC. August. Report prepared by the Congressional Research Service. 96/DDD.; Kevles, Daniel J. and Leroy Hood, Eds. (1992). The Code of Codes: Scientific and Social Issues in the Human Genome Project Cambridge, Mass., Harvard University Press.; U.S. Congress, House of Representatives, Committee on Science and Technology, Subcommittee on Investigations and Oversight, (1982). Human Genetic E n g i n e e r i n g. U.S. Government Printing Office. Washington, DC. November 16, 17, 18. Hearing. 97/170.; Cook-Deegan, Robert M., (1994). The Gene Wars: Science, Politics, and the Human Genome. New York, Norton and Co.; and Yesley, Michael S., (1992). Bibliography: Ethical, Legal, and Social Implications of the Human Genome Project. Washington, DC, U.S. Department of Energy, Office of Energy

Chapter 1


in his book, The Politics of Evolution.2 8

16

Desmond claimed that historians

had looked only to the writings of the elite and the clergy in documenting the reception of evolutionary theory.

Instead, Desmond

sought historical understanding in the radical non-conformist colleges and anatomy schools.

He developed a book that reflected the views of

obscure dissidents and heretofore unknown medical faculty.2 9 The official positions of high ranking or highly visible people and groups in the rDNA debate (such as Members of Congress, presidentially appointed agency heads, or the principal anti-rDNA activist, Jeremy Rifkin), have been well documented and are available in the public domain.

I have made liberal use of these documents.

But the views of

less powerful people with uncelebrated names have not been similarly well-recorded.

I have therefore chosen to interview and include the

views of former Congressional staffers, lower level federal employees, and former Reagan administration officials, in the expectation that a picture quite different from the authorized version might emerge. was not disappointed.

I

I have discovered that the actions of and the

interactions among these lesser known individuals had a profound effect on the direction taken by U.S. biotechnology policy. No determination about right or wrong in the controversy is attempted.

I deliberately present only limited details of the arguments

for and against rDNA technology because I choose instead to focus on underlying social factors which may have motivated players to take such positions in the first place.

I did not have access to all information.

Research. 28 Desmond, Adrian, (1989). The Politics of Evolution: Morphology, Medicine, and Reform in Radical London. Chicago, University of Chicago Press. 29 Ibid., p.11.

Chapter 1


17

Some players declined to be interviewed because they did not want to dredge up painful memories.

While it would be impractical to speculate

what possessed each individual to take one stand or another, it is possible to correlate positions in the rDNA debate or antagonistic personal relationships with other criteria such as membership in organizations or political affiliations.

Summary of Chapters In Part I, I introduce the background and context necessary to make clear my social history of the agricultural communityÕs role in the shaping of federal biotechnology regulation.

Chapter Two covers the

beginnings of agricultural biotechnology and the political milieu during the period before the rDNA debate began. period.

This is designated a gestation

Unlike living organisms, gestation periods of controversies may

not be visible except in retrospect.

The notion that controversies have

gestation periods as well as birth dates is expressed by Krimsky. Krimsky observed that Ò[s]cientific and social controversies, like living organisms, have not only birthdates, but also gestation periods.Ó3 0 Chapter Three reviews key events of the 1970s; what I shall call the ÒContainment EraÓ of the rDNA controversy.

The periods I will use to

characterize ÒerasÓ are modeled on FletcherÕs stages in the evolution of ethical debates. 30

Elements of JasperÕs technology controversy embedded

Krimsky, Sheldon, (1982). Genetic Alchemy: The Social History of the Recombinant DNA Controversy. Cambridge, MA, MIT Press. See p.13. Although I have used KrimskyÕs notion of ÒgestationÓ to label the first of my periods, perhaps Òlatent periodÓ would be a more appropriate designation. Latency implies a hidden period of growth (as in the early stage of bacterial culture growth or as in the non-symptomatic period before disease becomes evident) without the determinism that is implied by the term Ògestation.Ó That is, an organism ÒgestatingÓ is expected to follow a predictable path toward an objective. I will consider using the term ÔlatentÕ or ÔlatencyÕ in future work.

Chapter 1


in a political cycle will also be utilized.3 1

18

I describe a periodicity to the

Containment Era of the debate which is repeated in the next cycle of the rDNA controversy--the ÒRelease Era.Ó Part II, ÒLetting the Genie Out of the Bottle,Ó begins the main historical contribution of this work.

It begins, in Chapter Four, with the

early involvement of the U.S. Department of Agriculture (USDA) and the Land Grant System with the Recombinant DNA Advisory Committee (RAC) at the National Institutes of Health (NIH). the gestation period of the Release Era.

This chapter depicts

Chapter Five covers the

uncertainty experienced by the RAC as its responsibilities expanded to include review of the first agricultural protocols for release of rDNA into the environment.

Chapter Six highlights several events that reignited

public interest in rDNA as the controversy crossed a threshold and moved into the Release Era.

Chapter Seven illustrates the conflict of

perspectives in Washington, DC, regarding the release of rDNA into the environment and the ways in which the Republican Administration, the Democratic House of Representatives, and the radical critics of rDNA technology all employed rDNA policy as a political device. In Part III, ÒWho Will Control the Genie?Ó I turn to a deeper examination of the conflict of perspectives introduced in Chapter Seven as the controversy entered a crisis period.

Chapter Eight discloses how

the controversy troubled the USDA, setting internal division against division in a philosophical conflict over what form federal oversight of agricultural biotechnology should take. 31

In a single year, the USDAÕs

Fletcher, John C., (1990). ÒEvolution of Ethical Debate about Human Gene Jasper, James M., Therapy.Ó Human Gene Therapy. v. 1 (1) (Spring) pp. 55-68.; (1988). ÒThe Political Life Cycle of Technological Controversies.Ó Social Forces. v. 67 (2) (December) pp. 357-377.

Chapter 1


19

internal debate over rDNA went through all of the same stages in microversion, illustrating the multi-level periodicity that is characteristic of this controversy.

In Chapter Nine, I describe how the Reagan

Administration took control and instituted the Coordinated Framework for Regulation of Biotechnology, thus averting a crisis, without resolving the controversy.

Chapter Ten features the incompatibility of

biotechnology with primary critic Jeremy RifkinÕs belief system and his use of the controversy to agitate for radical social reform.

Chapter

Eleven takes the Release Era to the end of the decade and into a period of quasi-quiescence through the eyes of a group of Congressional staffers and their failed attempt to fix what they viewed as an Uncoordinated Framework. Finally, in Part IV, ÒLearning From the Genie,Ó I conclude my work in Chapter Twelve with an analysis of patterns and cycles in the history of the rDNA controversy and what we can learn from the study of this multi-dimensional history of science policy making.

PART I - BACKGROUND AND CONTEXT

ÒSo this, the central problem, remains almost unconsidered.

It

presents probably the largest ethical problem that science has ever had to face. ...With some relief, most biologists turn away from so vast and uncomfortable an issue and take refuge in the still knotty but infinitely easier technical questions: not w h e t h e r to proceed, but h o w. For going ahead in this direction may be not only unwise, but dangerous.

32

- George Wald, 1967 Nobel Laureate.

ÒAs one of the signers of the original moratorium, I apologize to society.

The question now is, what is the best way to get out of this

political mess?

Science is good for society.

We are being attacked by

everyone who doesn't have the guts to go ahead.

The dangers of this

thing are so slight--you might as well worry about being licked by a dog.

33

-James D. Watson, 1962 Nobel Laureate.

32

Wald, George, (1976). ÒThe Case Against Genetic Engineering.Ó The Sciences. v. 16 (September) p. 6+. Emphasis original. Wald shared in the 1967 Nobel Prize for his work in the physiology of vision. 33 Speech quoted in McAuliffe, Sharon and Kathleen McAuliffe, (1981). Life For S a l e. New York, Coward, McCann & Geoghegan. See p.176. Date of speech was not given. Watson shared in the 1962 Nobel Prize for his work in elucidating the double helical structure of DNA.

CHAPTER TWO: AGRICULTURE AND SOCIETY BEFORE BIOTECH Introduction The intent of this background chapter is twofold.

First I will

document two very early discoveries that have been given little attention by other rDNA debate historians and establish the relevance of these discoveries to the 1980s debate.

Second, I make a necessary

digression to characterize the sociopolitical milieu of the period leading up to the recombinant DNA (rDNA) debate.

The Beginnings of Agricultural Biotechnology Any comprehensive account of the biotechnology era must include the story of the first construction of recombinant molecules derived from DNA of different species in 1973 by Stanley Cohen and Herbert Boyer and their colleagues at Stanford University and the University of California, San Francisco.3 4

Most would not fail to mention James

WatsonÕs and Francis CrickÕs earlier discovery of the structure of DNA.3 5 An account of the rDNA controversy might even go back further to Oswald AveryÕs 1944 determination that DNA is the material of inheritance.3 6

34

Cohen, Stanley N., Annie C.Y. Chang, Herbert W.Boyer and Robert B. Helling, (1973). ÒConstruction of Biologically Functional Bacterial Plasmids In Vitro. Ó Proceedings of the National Academy of Science. v. 70 (11) (November) pp. 32403244. 35 Watson, J.D. and F.H.C. Crick, (1953). ÒMolecular Structure of Nucleic Acid: A Structure for Deoxyribose Nucleic Acid.Ó N a t u r e. v. 171 pp. 737-738. 36 Avery, O.T., C.M. MacLeod and M. McCarty, (1944). ÒStudies on the Chemical Nature of the Substance Inducing Transformation of Pneumococcal Types. Induction of Transformation by a Deoxyribonucleic Acid Fraction from Pneumococcus Type III.Ó Journal of Experimental Medicine. v. 79 pp. 137-158.

Chapter 2


22

My account, however, with its focus on the period of the controversy that is most relevant to the contemporary agricultural and environmental communities, begins with reference to two discoveries frequently overlooked by historians of the rDNA debate.

The first of

these contributions was made by Erwin F. Smith and Charles O. Townsend, employees of the USDA in the early 1900s, who studied the mechanism of the formation of crown galls in the cultivated marguerite, or Paris daisy.3 7

The second important contribution was made by

Barbara McClintock, a graduate of Cornell UniversityÕs College of Agriculture with a Ph.D. in botany, who, during her long tenure at the Cold Spring Harbor Laboratory, discovered so-called Òjumping genesÓ in maize.3 8

The three most detailed social histories of the rDNA debate all

neglect to mention the contributions of these agricultural researchers.3 9 Plant Tumors and DNA Transfer

Smith and Townsend, remarkably as early as 1907, made a Òbreakthrough ... discovery that plants are commonly altered genetically in nature in much the same way that bacterial chromosomes can be integrated with the DNA of viruses,Ó although, at the time, the researchers Òwere unaware that they were observing a natural DNA

37

Smith, Erwin F. and Charles O. Townsend, (1907). ÒA Plant-Tumor of Bacterial Origin.Ó S c i e n c e. v. 25 (April 26) pp. 671-673. 38 Keller, Evelyn Fox, (1983). A Feeling for the Organism: The Life and Work of Barbara McClintock. New York, W.H.Freeman and Company. See p.2. Maize (Zea m a y s) is the wild ancestor of corn and is commonly used in plant genetics research. Popularly referred to as ÒIndian corn,Ó it has multi-colored kernels. 39 Watson, James D. and John Tooze, (1981). The DNA Story: A Documentary History of Gene Cloning. San Francisco, W. H. Freeman and Company.; Krimsky, Sheldon, (1982). Genetic Alchemy: The Social History of the Recombinant DNA Controversy. Cambridge, MA, MIT Press.; Wright, Susan, (1994). Molecular Politics: Developing American and British Policy for Genetic Engineering, 1972-1982. Chicago, University of Chicago Press.

Chapter 2 transfer.Ó4 0


23

Smith had inferred a connection between the formation of a

tumor-like crown gall and cancer in humans and animals4 1 and had hypothesized that they were in both cases caused by Òparasites that remained unidentified.Ó4 2

The cancer connection made SmithÕs work of

particular interest to the American Medical Association and also to the National Institutes of Health (NIH), which funded his continued agricultural research.4 3 The organism that causes crown gall, Agrobacterium tumifaciens, is a common soil bacterium, which, on gaining access into a fresh wound on a plant, is capable of integrating any DNA it carries into the genome of the plant and causing a tumorous growth.

Today, A. tumifaciens with

its Ti plasmid4 4 is one of the most commonly used living tools for molecular transfer of DNA from various sources into plants. general are widely used for this purpose.

Plasmids in

Scientists can delete the

portion of the DNA in the plasmid that causes disease symptoms and replace it with whatever sequence they wish to introduce into a plant.

40

Schor, Joel, (1994). The Evolution and Development of Biotechnology: A Revolutionary Force in American Agriculture. Washington, DC, US Department of Agriculture, Economic Research Service, A&RE Division. See p.9. 41 Smith, Erwin F. and Charles O. Townsend, (1907). ÒA Plant-Tumor of Bacterial Origin.Ó S c i e n c e. v. 25 (April 26) pp. 671-673. See p.671. 42 Schor, Joel, (1994). The Evolution and Development of Biotechnology: A Revolutionary Force in American Agriculture. Washington, DC, US Department of Agriculture, Economic Research Service, A&RE Division. See pp.8,9. 43 Ibid. at p.9. 44 A plasmid is a small circular piece of DNA that ÒhitchhikesÓ in the bacterial cytoplasm. The ÔTiÕ (tumor-inducing) plasmid is incorporated into the host plantÕs genome and instructs the cell to make food for the bacteria as well as to generate more identical plant cells capable of making more food. Hence, a tumor forms at the site of infection. LappŽ, Marc, (1984). Broken Code: The Exploitation of DNA. San Francisco, Sierra Club Books., in Appendix E.

Chapter 2


24

ÒJumping GenesÓ - NatureÕs Own Genetic Engineering

The second contribution of significance to the history of agricultural biotechnology was made during the 1940s by Barbara McClintock, who demonstrated that sections of DNA in maize, the wild ancestor of corn, had the ability to relocate on the chromosomes (i.e., recombine) and even to perform different functions at their new locations.4 5 McClintock called this behavior Òtransposition.Ó

It was subsequently

discovered that the sequence of DNA remains in its original location while one or more duplicate copies of the sequences are inserted into new locations.4 6

This is significant because more copies of a coding

sequence will enhance the synthesis of a protein product that is otherwise produced in smaller quantities.

Using the molecular

techniques now available, scientists could imitate this natural phenomenon.

For example, the levels of selected amino acids in corn

that are essential to the human diet, but normally produced in smaller quantities, could be enhanced. The significance of McClintockÕs discovery, like that of Gregor MendelÕs in the last century, went unappreciated by geneticists and molecular biologists for decades.

The ability of genomic DNA to

rearrange itself and function differently in its new location, remained unrecognized until well into the age of molecular biology when the same phenomenon was discovered to be occurring in bacteria such as E. coli.4 7 45

McClintockÕs work was documented in a series of reports in the C a r n e g i e Institution of Washington Yearbooks (1946, 1947, 1948, 1949). For review, see Chapters Seven and Eight in Keller, Evelyn Fox, (1983). A Feeling for the Organism: The Life and Work of Barbara McClintock. New York, W.H.Freeman and Company. 46 Tamarin, Robert H., (1986). Principles of Genetics. Boston, MA, Prindle, Weber, and Schmidt Publishers. See p.512. 47 Keller, Evelyn Fox, (1983). A Feeling for the Organism: The Life and Work of

Chapter 2 Investigative


25

Irony

Smith/Townsend and McClintock all performed their investigations in the agricultural tradition, unregulated and in the open air, long before the public discussions of health and environmental safety issues surrounding biotechnology research became popular.

They observed

and documented nature itself to be engaging in what was later acknowledged as recombinant DNA activities, without any interference from scientists, without the protection of a high security laboratory, and without causing any apparent harm to or concern for the safety of the researchers or the environment in which samples were grown.

I bring

these historical oversights to the readerÕs attention not only for completeness, but also for the ironies in them. Both of the early discoveries described above illustrate that rDNA was not a revolutionary, new, human invention first conceived in a university laboratory in 1973.

Recombination is a natural process that

can occur within a cell whenever DNA replicates itself or between some organisms, even of different species, when cells come in close contact with one another.

The discovery that nature recombines DNA on its

own is what prompted researchers to experiment with manipulating it in the first place.

CohenÕs and BoyerÕs rDNA protocol, something so new,

useful, and non-obvious that it qualified as patentable, should be considered revolutionary only in the sense that it represented the discovery of the means by which to transfer specific, functional pieces Barbara McClintock. New York, W.H.Freeman and Company. See p.182-185. McClintockÕs awards for cytogenetics (the study of heredity using non-molecular techniques) brought her worldwide attention and included the first MacArthur Laureate Award in 1981--a fellowship of $60,000 a year for life (Keller, p.13). Only after her concept was clarified in molecular terms did McClintock finally receive a Nobel Prize in 1983 for the discoveries she had made more than 35 years earlier.

Chapter 2


26

of DNA from one location to another--even between species--in a controlled manner.4 8 In April of 1980, many decades after McClintockÕs documentation of what was later shown to be natural recombination in maize, the RAC received a proposal from Dr. Ronald W. Davis of Stanford University to field test corn which had been modified using rDNA techniques.4 9 The proposal, according to RAC member Sheldon Krimsky, was to grow in an open field corn plants in which some of the DNA had been modified using molecular techniques so as to enhance the production of two amino acids that are normally deficient in corn, thus improving its value to the human diet.5 0

As described by Krimsky, Davis and his team

wanted to insert into corn what amounted to extra copies of existing genes, thus imitating McClintockÕs nonrecombinant experiments in maize by using rDNA techniques.

First, however, the researchers

wanted to use rDNA to effect the initial insertion of the extra corn genes into the developing grains of the corn, a n d they wanted to do this in an outdoor experimental plot where corn can be grown more effectively than in controlled laboratory or greenhouse environments.5 1

48

US Patent No. 4,237,224; December 2, 1980. (45 FR 28907). 50 Krimsky, Sheldon, (1987). ÒGene Splicing Enters the Environment: The SocioHistorical Context of the Debate Over Deliberate ReleaseÓ in Application of Biotechnology: Environmental and Policy Issues. J. R. Fowle, III, Ed. Boulder, CO. Westview Press for the American Association for the Advancement of Science. pp. 27-53. See p.35. This application was not in the original protocol, but the hope was that such an application could eventually be realized. Davis reported having had many conversations with Barbara McClintock about the project. Telephone interview with Ronald W. Davis, Ph.D. Professor of Biochemistry, Stanford University (September 23, 1999). 51 Personal communication with Sue A. Tolin, Ph.D. Professor of Plant Pathology, Physiology, and Weed Science, Former USDA representative to the NIH-RAC and OECD. Virginia Tech (various dates in 1998, 1999). 49

Chapter 2


27

The planting of maize with its spontaneously jumping genes has never been forbidden by any federal rule.

Nevertheless, approval of

the Davis protocol required the federal granting of an exemption to Section I-D-4 of the NIH Guidelines that prohibited deliberate release into the environment of any organism containing recombinant DNA. 5 2 Getting approval from the RAC to exempt the experiment from the NIH Guidelines so the corn could be grown outdoors took almost a year and a half.

It is noteworthy that as of August 7, 1981, at which time the Davis

corn proposal was approved, there had been no public comments received regarding this landmark notice in the Federal Register.5 3 Another very early request for exemption to the prohibition against environmental release of organisms containing rDNA involved a common soil bacterium from which a segment of DNA had been deleted. According to Krimsky, this protocol was particularly controversial because although Òthere was an established tradition of introducing hybridized plants into the environment ... no analogous tradition existed for microorganisms.Ó5 4

Krimsky was referring to the memorable ÒIce-

MinusÓ experiment, which will be described in more detail throughout this dissertation.

The agricultural tradition of working with

microorganisms, such as those that produce crown galls, was not acknowledged by Krimsky. In short, ÒIce-MinusÓ was a variant of the bacterium, Pseudomonas syringae created using rDNA techniques. 52

The wild type organism,

(45 FR 6724) (46 FR 40331). 54 Krimsky, Sheldon, (1987). ÒGene Splicing Enters the Environment: The SocioHistorical Context of the Debate Over Deliberate ReleaseÓ in Application of Biotechnology: Environmental and Policy Issues. J. R. Fowle, III, Ed. Boulder, CO. Westview Press for the American Association for the Advancement of Science. pp. 53

Chapter 2


28

commonly found on plant surfaces, possesses a gene which produces a protein that facilitates ice crystal formation at temperatures near freezing.

Ice-minus had the corresponding gene deleted.

deletion can also occur spontaneously.)

(Such a

Ice-Minus was designed to be

sprayed on crops, such as strawberry plants, to displace the resident wild-type bacteria.

In the near absence of ice crystal inducing proteins

on the plant surfaces, plants can briefly withstand temperatures as low as 23 degrees Fahrenheit before frost damage occurs, because dew can be cooled to that point before it freezes.5 5 The McClintock and Smith/Townsend studies are thus relevant to the 1980s debate in which the safety of corn and soil organisms suddenly became questionable within a new context.

Experimentation with

organisms that were once investigated freely in the fields of agricultural researchers, who collectively had centuries of experience with experimental manipulation of genetic information in food production activities, suddenly came under the suspicious eye of public scrutiny. Somehow, mutant variants that were generated with purpose by human design were seen as potentially more dangerous to human or environmental health than those generated randomly by nature (or by researchers using traditional techniques).

In other words, the process

by which rDNA products were made had become more suspect than the products themselves.5 6

27-53. See p.36. 55 Maranto, Gina, (1984). ÒAttack on the Gene Splicers.Ó D i s c o v e r. v. (August) pp. 19-25. See p.20. 56 The distinction between ÔproductÕ and ÔprocessÕ would become important later in the rDNA debate. See Chapter Nine.

Chapter 2


29

The concern over the possible hazards of rDNA was viewed as absurdly excessive by some scientists.5 7

However, the caution that

would be exercised in the 1980s with regard to release of rDNA organisms into the environment was characterized by others as necessary to ensure public health and environmental safety.

What

could have provoked critics so much that the federal government felt it necessary to regulate the study of corn and naturally occurring microorganisms based on speculative hazard?

Why would the

government of an economic world leader consider restricting the investigative freedom of the scientists who contributed to that leadership?

To answer these questions, I must first review the social

context in which the debate gestated.

The Golden Age of American Science in Society At mid-20th Century, scientists generally were held in high esteem by the American public.

For example, science historian, Daniel Kevles

wrote that physicists had become an ÒestablishmentÓ of their own, having been generously funded with tax money, without the burden of public accountability.5 8

Likewise, Krimsky wrote, ÒIn the early 1950s,

the moral responsibility of science was synonymous with its selfrealization.

Science was viewed both as inherently virtuous and as the

engine of human progress.Ó5 9

Science and technology had made the U.S.

a respected world power, an economic leader, a bountiful producer of agricultural products, and one of the wealthiest countries on earth. 57

See for example, Miller, Henry I., (1997). Policy Controversy in Biotechnology: An Insider's View. Austin, R.G.Landes Co. 58 Kevles, Daniel J., (1977). The Physicists. New York, Knopf, Inc. See p.392. 59 Krimsky, Sheldon, (1991). Biotechnics and Society: The Rise of Industrial G e n e t i c s. New York, Praeger. See p.15.

Chapter 2


30

University scientists in particular were regarded as reliable sources of information because they were expected to adhere to the norms of the academic ethos, which required researchers to be forthcoming, impartial, disinterested, and non-partisan in their pursuit of truth. 6 0 In the academic Ivory Tower, intellectual inquiry and expression enjoyed relative freedom from outside interference. Wartime efforts had provided abundant grant opportunities for science and technology.

In his July, 1945 report entitled Science the

Endless Frontier, Vannevar Bush, chief science advisor to President Franklin D. Roosevelt, recommended the establishment of a new government agency that would provide financial support to advance essential progress in basic science.6 1

Bush advocated private

administration of the proposed agency, with self-policing to keep it Òsafely insulated from public accountability,Ó implying that scientists were too honest to require overview.6 2

After much Congressional

haggling, the National Science Foundation was established in 1950.6 3 In

60

The norms of the academic ethos are described in Merton, Robert, (1973). T h e Sociology of Science: Theoretical and Empirical Investigations. Chicago, IL, University of Chicago Press. 61 Bush, Vannevar, (1945). Science: The Endless Frontier: A Report to the President on a Program for Postwar Scientific Research. Washington, DC, National Science Foundation. 62 Kevles, Daniel J., (1977). The Physicists. New York, Knopf, Inc. See p.363. Bush, Vannevar, (1945). Science: The Endless Frontier: A Report to the President on a Program for Postwar Scientific Research. Washington, DC, National Science Foundation. See p.9. 63 An unsuccessful counter attempt by Senator Harley Kilgore (D-WV) to channel public funding for science into a centrally controlled agency dedicated to the use of science to satisfy social needs is examined by Penick, James L., Jr., Carroll W. Pursell, Jr., Morgan B. Sherwood and Donald C. Swain, Eds. (1965). The Politics of American Science: 1939 to the Present. Rand McNally History Series. Chicago, Rand McNally. See especially p.73; Also Kevles, Daniel J., (1977). The Physicists. New York, Knopf, Inc. See p.344. KilgoreÕs 1942 bill, the ÒTechnological Mobilization ActÓ (S.2721, 77 Congress, 2nd.) would have authorized the establishment of an agency that would have had Òfull access to all governmental

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the end, said Daniel Kevles, author of The Physicists, the establishment of the NSF was a Òvictory for elitism,Ó and academic freedom was p r e s e r v e d .6 4 Science was becoming securely established in national power and politics.

Vannevar Bush and his supporters, who were Òclosely allied

with a few powerful institutions and large corporations (where most wartime research was conducted)...Ó were opposed to inclusion of the social sciences, but wanted to use public resources to advance the needs of science, especially in basic research.6 5 Despite an eerie feeling of regret after seeing the first atomic mushroom cloud, public funding for and confidence in science and technology continued to be high.

Throughout the 1950s, the military-

industrial-university complex amassed more money, scientific projects, and political power as it cooperatively engaged in the Cold War effort, which included the space program and research in the life sciences. World War II had a Òrevolutionary effect on medical research,Ó causing the federal government to pour Òhuge sums of money into medical investigations.Ó6 6

For the next 20 years there would be Òno indication ...

that the wartime increase of Federal activities in medical research [would] be reversed.Ó6 7

and private informationÓ as well as authorization Òto review all projects for research and development [relevant to the Act]....Ó Relevant parts of the bill are reproduced in Penick et al. See p .84. Emphasis added. 64 Kevles, Daniel J., (1977). The Physicists. New York, Knopf, Inc. 65 Penick, James L., Jr., Carroll W. Pursell, Jr., Morgan B. Sherwood and Donald C. Swain, Eds. (1965). The Politics of American Science: 1939 to the Present. Rand McNally History Series. Chicago, Rand McNally. See p.121. Parentheses original. 66 Ibid., at p.157. 67 Ibid., at p.159.

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The Radical Ô60s and The Erosion of Public Trust in Science In order to appreciate fully a justification of the actions of some players in the 1980s rDNA debate, it is necessary to recall the tumultuous 1960s which so strongly influenced the formative years of those participants. In his 1961 farewell address to the nation, President Dwight D. Eisenhower warned of the Òdanger that public policy could itself become the captive of a scientific-technological elite.Ó

He cautioned that Òthe

acquisition of unwarranted influences ... by the military-industrial complexÓ might even in universities, create a situation where Òa government contract becomes virtually a substitute for intellectual curiosity.Ó6 8

By this time, the unpopular Vietnam War was Òalready

sucking the United States into its vortex.Ó 6 9

It was portentous that

Eisenhower, a former military general and Columbia University president, would call attention to the potential corruption of such a coalition. Opposing ÒThe EstablishmentÓ: The SDS and the New-Left Movement7 0

Especially important to the social underpinnings of the ensuing biotechnology debate is the radical political element that flourished during the 1960s.

68

The New-Left was characterized by its youthful

Raymond, Jack, (1961). ÒThe 'Military-Industrial Complex': An Analysis.Ó N e w York Times. New York. January 22, p. E4. DuShane, Graham, (1961). ÒFootnote to History.Ó S c i e n c e. v. 133 (no.3450) (February 10) p. 355. 69 Unger, Irwin, (1974). The Movement: A History of the American New Left, 19591972. New York, Dodd, Mead & Co. See p.28. 70 For a detailed social history of the New-Left, the reader is referred to Unger, Irwin, (1974). The Movement: A History of the American New Left, 1959-1972. New York, Dodd, Mead & Co., upon which I have depended heavily for this section.

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33

membership of white middle class college students and young professionals who led a nationwide movement for social change.

Not

yet having a vested interest in corporate America, these young idealists were free to express their anger and frustration in the name of those who had slipped through the cracks during the rise of the Òaffluent society.Ó

They believed they had exposed a Òfalse consciousnessÓ

imposed upon Americans by a system that was enslaving its citizens in an existential way.7 1

The radically liberal organization, Students for a

Democratic Society (SDS), was the student component of the New-Left political movement. The New-Left movement impressed upon a generation the idea that the universities were hardly the Ivory Towers of free intellectual expression they professed to be, but in fact were Òno better than the society that surrounded themÓ because they Òcombined oppression and coercion with hypocrisyÓ as they joined forces with the warfare state by churning out workers as though they were exchangeable parts.7 2 As mentioned earlier, scientists, particularly physicists, had become part of the elite Òestablishment.Ó7 3

UniversitiesÕ actions, like the actions of the

United States in Vietnam, were seen by the students as a misuse of power.7 4

The students wanted to replace oppressive Establishment

rules with a Òparticipatory democracyÓ in which everyone has a right to decide.

71

Ibid. See especially p. vi, p. 26, and p. 29. Ibid. at p. 80. 73 Kevles, Daniel J., (1977). The Physicists. New York, Knopf, Inc. See p.392. 74 Daniel Yankelovich Inc., (1979). ÒThe New Morality: A Profile of American Youth in the '70'sÓ in Student Political Involvement in the 1970's. J. Peter Segall and Robert M. Pickett, Eds. Port Washington, New York. National University Publications. . See p.122. 72

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34

In early 1965, President Lyndon B. Johnson put fuel on the fire by approving an escalation of military involvement in Vietnam.

Through

guilt by association with the military-industrial complex, the Ivory Towers began to look muddy.

The social turbulence endured by the

Ô60Õs generation came to a head in 1968 with riot torn campuses and a yippie showdown at the Democratic National Convention in Chicago.7 5 No doubt many things contributed to the demise of the New-Left movement.

Perhaps it was because of police repression at the time of

the 1968 presidential elections.7 6 national leadership.7 7

Perhaps it was the dissolution of SDS

Maybe as President Richard M. Nixon, who took

office in 1969, began gradual withdrawal of troops from Vietnam, a major raison dÕ•tre became moot.

Many radicals were probably co-

opted by liberal Democrats who also opposed the strongly conservative Nixon Administration.

The black insurgency,7 8 womenÕs liberation

movements, and other social causes such as environmentalism undoubtedly fragmented and redirected New-Left energies.

Or perhaps

it was simply due to the reality of growing up and giving in to the pressures of career and family.

By the early 1970s, a central theme on

campuses had evolved from searching for self-fulfillment in place of a conventional career to how to find self-fulfillment w i t h i n a conventional career.7 9 75

In 1967, Abbie Hoffman and Jerry Rubin co-founded the Youth International Party (yippies), a radical anti-establishment political group. Unger, Irwin, (1974). The Movement: A History of the American New Left, 1959-1972. New York, Dodd, Mead & Co. See p.132. 76 Rothman, John, Ed. (1968). New York Times Index New York. 77 Unger, Irwin, (1974). The Movement: A History of the American New Left, 19591972. New York, Dodd, Mead & Co. See p.90. 78 McAdam, Doug, (1982). Political Process and the Development of Black Insurgency, 1930-1970. Chicago, University of Chicago Press. 79 Daniel Yankelovich Inc., (1979). ÒThe New Morality: A Profile of American

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Despite reports of its demise, however, the New-Left appears to have found resurrection, at least in part, in the Green Party.

Rural sociologist,

Frederick Buttel, has written on the origins of environmentalism and describes ÒgreeningÓ as a New Social Movement.8 0

Buttel presents many

characteristics of greening that correspond to the New-Left Movement, such as working class origins, social-justice orientation, and rejection of modern institutional practices.

Like the New-Left before them, many of

todayÕs greens distrust the intentions of life scientists who work for established institutional structures such as government and industry. Enter A Soon-To-Be Familiar Figure To Biotech

The SDS, the New-Left, and the concept of Òparticipatory democracyÓ are all remarkably relevant to the later activities of Jeremy Rifkin, the most outspoken critic of modern biotechnology.

ÒHad it not been for

[the way the Vietnam War] issue grabbed me,Ó said Rifkin in a 1984 interview, ÒI donÕt know what IÕd be doing today.Ó8 1 A New York Times article reported that Rifkin Òhelped sponsor a major rally against the Vietnam War in New York in 1967 and helped stage a mock war-crimes trial against the United States in Washington in 1970.Ó8 2 Rifkin is the founder and President of the Foundation on Economic Trends (FET) in Washington, DC. The FET had grown out of the PeopleÕs Business Commission, which in turn had previously been called the Youth in the '70'sÓ in Student Political Involvement in the 1970's. J. Peter Segall and Robert M. Pickett, Eds. Port Washington, New York. National University Publications. . See p.120. Emphasis original. 80 Buttel, Frederick H., (1992). ÒEnvironmentalism: Origins, Processes, and Implications for Rural Social Change.Ó Rural Sociology. v. 57 (1) pp. 1-27. 81 Current Biography Yearbook 1985. (1986). Moritz, Charles, ed. . H.W.Wilson Co. New York. , p.468. 82 Boffey, Philip M., (1984). ÒAn Activist Takes on Genetic Engineering.Ó N e w York Times. New York. April 11, p. B10.

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PeopleÕs Bicentennial Commission (PBC).

36

The PBC, co-founded by Rifkin

and Pentecostal minister, Ted Howard, was Ò[c]onceived out of the turmoil and trauma of the late Ô60s, and dedicated to ... [engendering a grass-roots] Second American Revolution ... aimed against economic royalty and concentrated wealth and power,Ó in other words, multinational corporations and their stockholders.8 3 Rifkin lamented the demise of the New-Left.

He blamed its failure

on its insistence upon pursuing Òa single strategy of confrontation, even when its continued use (was) alienating and ineffective.Ó8 4 Rifkin, who had graduated from the Wharton School of Finance at the University of Pennsylvania in 1967 with a bachelorÕs degree in economics, and from the Fletcher School of Law and Diplomacy at Tufts University in 1968 with a masterÕs degree in international affairs, still uses New-Left, rhetoric in his writings.

While it is certainly possible for authors to

construct identical terms independently, the frequency with which phrases and terms that were used in SDS publications can be found in RifkinÕs books (for example, Òparticipatory democracyÓ) clearly suggests that he had internalized the language of the New-Left.

His remarkably

consistent message over the last 20 years of writings clearly spells out his political philosophy in no uncertain terms; that wealthy multinational corporations must be disenfranchised for the good of society.

Jeremy Rifkin, his philosophy, and his subsequent campaign

against rDNA will be featured in Chapter Ten of this work.

83

Howard, Ted, (1976). The P.B.C.: A History. Washington, DC, The People's Bicentennial Commission. See p.5. 84 Rifkin, Jeremy and John Rossin, (1973). How to Commit Revolution American S t y l e. Secaucus, New Jersey, Lyle Stuart, Inc. See p.139.

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Public Distrust of Science and Technology

In addition to condemning the atrocities of war, activists of the 1960s brought other hidden costs of technology development to the attention of a public that eventually became skeptical of the Òtrust me, just send moneyÓ approach to scientific research.

For example, attorney

Ralph Nader, beginning with his 1965 exposŽ, Unsafe at Any Speed, about the hazards built into the American automobile, became a popular consumer protection watchdog.8 5 During the 1960s, notice was taken of the polluting effect of industrial emissions on natureÕs air and water and the young nuclear power industry was plagued with engineering and safety problems.8 6 The pollution issue led to the passage of the National Environmental Protection Act (NEPA) in 1969 (Public Law 91-190) and the establishment of the Environmental Protection Agency (EPA) in 1970. At the end of the 1960s, the popularity of environmentalism was on the rise.

Between 1968 and 1970, the number of column inches of the

New York Times devoted to environmental issues began an exponential increase.8 7

Membership in the Sierra Club more than tripled between

1967 and 1977, while the National Audubon Society showed a five-fold increase in membership during the same period.8 8 Concerns about the hubris of science were not limited to nonscientists, however. 85

The technological benefits of the green

Nader, Ralph, (1965). Unsafe at Any Speed: The designed-in dangers of the American automobile. New York, Grossman. 86 Downey, Gary L., (1986). ÒThe American Conflict Over Nuclear Power.Ó C u l t u r a l A n t h r o p o l o g y. v. 1 (4) (November) pp. 388-412. See pp.399, 397. 87 Sandbach, Francis, (1980). Environment, Ideology, and Policy. Oxford, Basil Blackwell. See p.5. 88 Ibid. at p. 15. Sandbach, Francis, (1980). Environment, Ideology, and Policy.

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38

revolution in American agriculture were tarnished by the disclosure of the role of pesticide residues in vanishing wildlife by marine biologist Rachel Carson.

In her landmark book, Silent Spring, Carson questioned

the ability of science to assess effectively the risks of using chemical pesticides such as DDT.8 9 By 1969, a group of physicists had formed Scientists and Engineers for Social and Political Action (later, Science for the People) which Òrapidly progressed from questioning the scientistÕs moral and social responsibilities to a full-blown critique of American capitalism.Ó9 0 Science for the People is an organization for Òscientists and others concerned about the social implications of science and technology.Ó9 1 The radically liberal organization has been described as Òa group of new-left scientists in Cambridge and Boston, which included several molecular biologists.Ó9 2 The very politicization of science is what makes it more subject to public scrutiny.

That trained scientists on both sides of a science policy

issue have been known to give conflicting Òscientific evidenceÓ in scientific debates, has been explored by science studies historian, Brian Martin, in the controversy over fluoridation of water to prevent tooth decay.9 3

When the safety to humans and the environment of some

kinds of scientific research and development comes into question, whom Oxford, Basil Blackwell. 89 Carson, Rachel, (1961). Silent Spring. New York, Fawcett Crest Books. 90 Krimsky, Sheldon, (1982). Genetic Alchemy: The Social History of the Recombinant DNA Controversy. Cambridge, MA, MIT Press. See p.20. 91 Maurer, C. and T.E. Sheets, Eds. (1999). Encyclopedia of Associations Detroit, MI, Gale Publishing. See p.770. 92 Watson, James D. and John Tooze, (1981). The DNA Story: A Documentary History of Gene Cloning. San Francisco, W. H. Freeman and Company. See p.27. 93 Martin, Brian, (1991). Scientific Knowledge in Controversy: Ths Social Dynamics of the Fluoridation Debate. Albany, NY, SUNY Press.

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is the public to believe when for every expert there is an equal and opposite expert?

In the case of rDNA, some public interest groups

began to look to the federal government not only for funding of science, but for protection f r o m science.

Summary In this chapter, I have presented early discoveries and political events which are relevant to my account of the 1980s debate about release of rDNA into the environment.

I gave examples of early

agricultural research with plant pathogens and crops that had taken place in traditional outdoor locations.

The experimental organisms

engaged in recombinant activities naturally without human intervention, without stringent public oversight, and without apparent mishap. I also examined the political milieu just prior to the advent of genetic engineering.

Science was already entwined with politics long before

biotechnology became a familiar word on Capitol Hill.

It may be that

the politicization of science is what made it more subject to public scrutiny.

Finally, I connected that milieu of public distrust of

government and science with the radically liberal and outspoken critic of biotechnology, Jeremy Rifkin. In the next chapter, I will review key events of the negotiation of biotechnology policy in the 1970s in order to provide a frame of reference for the debate of the 1980s.

CHAPTER THREE: HIGHLIGHTS OF THE EARLY BIOTECH DEBATE: THE ERA OF CONTAINMENT Introduction In this chapter, I cover what I call the ÒContainment EraÓ of the rDNA debate.

That era can be subdivided into several periods, corresponding

to FletcherÕs stages in the evolution of ethical debates.9 4

The beginning

and ending dates of these periods are approximate, and overlap in some instances.

The gestation period, visible only in retrospect, came to an

end in 1973, with the discovery of the means to transfer pieces of DNA from one organism to another of a different species (threshold). An important sequence of events occurred in the early 1970s which propelled biotechnology into the popular press, the courtroom, and the realm of science and technology studies.

Because the rDNA story of the

1970s has been well documented by others, it is not necessary to repeat their laudable efforts.9 5

However, a review of certain landmark events

is essential to the understanding of incidents that transpired later.

The

milestones of biotechnology regulation in the 1970s include: 1 . the recognition that scientists were forging an extremely powerful technology, 2 . the voluntary self-imposition of the first discipline-wide research moratorium in the history of science, which polarized the debate, 94

Fletcher, John C., (1990). ÒEvolution of Ethical Debate about Human Gene Therapy.Ó Human Gene Therapy. v. 1 (1) (Spring) pp. 55-68. 95 Watson, James D. and John Tooze, (1981). The DNA Story: A Documentary History of Gene Cloning. San Francisco, W. H. Freeman and Company. Krimsky, Sheldon, (1982). Genetic Alchemy: The Social History of the Recombinant DNA Controversy. Cambridge, MA, MIT Press. Wright, Susan, (1994). Molecular Politics: Developing American and British Policy for Genetic Engineering, 1972-1982. Chicago, University of Chicago Press.

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3 . the establishment of the Guidelines For Research Involving Recombinant DNA Organisms by the NIH, and 4 . the gradual relaxation of those Guidelines. This expression of scientific uncertainty in the form of a self-imposed moratorium on research provided a catalyst for conflict over control of the technology and threw the controversy into a crisis/ conflict period. Only after government action and the discovery of Ònew dataÓ did the controversy evolve slowly at the end of the decade into a q u a s i quiescent period. In this chapter, as well as in later ones, I emphasize that the rDNA debate was not simply one of knowledgeable scientists on the one hand and a fearful, scientifically illiterate public on the other.

Scientists were

as divided on rDNA issues as they were in their world views and politics--and this is the k e y to understanding the social underpinnings of the rDNA controversy.

Earliest Congressional Discussion Political scientist, L. Christopher Plein, has traced the first Congressional biotechnology policy discussions to 1968 when hearings were held by the Senate Committee on Government Operations to consider the potential ethical consequences of genetic engineering.9 6 In that year, Senator Walter Mondale (D-MN) had submitted for consideration a Senate Joint Resolution to establish a Commission on Health Science and Society which would assess and publish a report on the ethical, legal, social, and political implications of biomedical

96

Plein, L. Christopher, (1990). ÒBiotechnology: Issue Development and EvolutionÓ in Biotechnology: Assessing Social Impacts and Policy Implications. D. J. Webber, Ed. Westport, CT. Greenwood Press. . See p.148.

Chapter 3 advances.


42

The proposed Commission would have included professionals

from such fields as law, theology, ethics, and philosophy, in addition to scientists.9 7 The hearings on this bill ran an unusually long 7 days during which witnesses, primarily medical professionals and academics, presented testimony.9 8

Senator Fred Harris (D-OK), chairman of the Subcommittee

on Government Research, in his opening remarks for the hearings, summarized their purpose: ÒThe critical question at this juncture seems to be: Are our social institutions, national resources and national policies able to keep pace with the new medical techniques, the increased impact of biomedical innovation and the evolving character of the doctor-patient relationship?9 9 Despite the attention given to a perceived need for public discussion prior to development of genetic engineering technology, the bill failed to pass.

Plein concluded that the early efforts of the Congress (in 1968,

1971, and again in 1972) to establish commissions to evaluate social, ethical, and legal implications of genetic engineering in advance of the impending technology were not brought to fruition in large part due to lack of public support (for example, as could have been expressed in letters and telephone calls to Congressional representatives) for concerns that were not pressing realities.1 0 0

97

At the time, genetic

(S.J.Res.145, 90th Congress, 2nd Session.) U.S. Congress. Senate. Committee on Government Operations, Subcommittee on Government Research, (1968). National Commission on Health Science and Society. U.S. Government Printing Office. Washington, DC. March 7, 8, 21, 22, 27, 28, April 2. Hearing. 74-6. 99 Ibid. See p.3. 100 Plein, L. Christopher, (1990). ÒBiotechnology: Issue Development and EvolutionÓ in Biotechnology: Assessing Social Impacts and Policy Implications. D. J. Webber, Ed. Westport, CT. Greenwood Press. . See p. 150. 98

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43

researchers framed the issue as one of academic freedom, while critics focused on the ethics of using the new technology in humans, which might have revived a eugenics program and the specter of a Brave New World.1 0 1

During this early period, biotechnology and direct genetic

manipulation of humans was only theoretical.

The debate, Òcompared to

events to come, was low-key, and confined to the concerns of relatively few actors.Ó1 0 2

It was the calm before the storm.

Asilomar I and the ÒSinger-Soll LetterÓ In 1971, molecular biologist Paul Berg,1 0 3 , contemplating the celltransforming properties of the tumor-producing primate virus SV-40, began to think about using it as a vector to bring new genetic material into other organisms, although at the time the technology to do so was not yet available.1 0 4

Apprehension about BergÕs ideas led to concerned

discussions at professional meetings.1 0 5

In January of 1973, a meeting

was held at the Asilomar Conference Center in Pacific Grove, California (ÒAsilomar IÓ), entitled ÒBiohazards in Biological Research.Ó

The

conference focused on the risks and benefits of research using tumor

101

Ibid. at p. 151.; Huxley, Aldous, (1946). Brave New World. New York, Harper & Row. 102 Ibid. at p. 149. 103 Paul Berg shared the 1980 Nobel Prize in Chemistry (one half) for his pioneering work in recombinant DNA. The other half of the Nobel Prize that year went to Walter Gilbert and Frederick Sanger, for their determination of base sequences in nucleic acids. Nobel Prize Internet Archives, (date of posting not given). ÒNobel Prize in Chemistry Winners1996-1901Ó. Accessed October 19, 1998. 104 Krimsky, Sheldon, (1982). Genetic Alchemy: The Social History of the Recombinant DNA Controversy. Cambridge, MA, MIT Press. See p.59, p.37. 105 Lewin, Roger, (1991). ÒThe Asilomar Conference: Was the Asilomar Conference a Justified Response to the Advent of Recombinant DNA Technology, and Should It Serve as a Model for Whistle-Blowing in the Future?Ó in Bioscience « Society; Report of Schering Workshop. D. J. Roy, B. E. Wynne and R. W. Old, Eds. Chichester, NY. John Wiley & Sons. pp. 203-210. See p.204.

Chapter 3 viruses.


44

At that meeting, one of the conference organizers, Michael

Oxman of the Harvard Medical School, made the following statement regarding the concept of informed consent for personnel who would be working within the laboratories. ÒWhereas an investigator may himself decide to assume certain risks, he does not have the right to make that decision for anyone else. In fact, it seems to me that the decision to assume a risk can only legitimately be made by the individual who will be in jeopardy.Ó1 0 6 Oxman went on to say that because it would be impractical to extend this right to people not working directly with rDNA organisms, every effort must be made to ensure containment.

His significant reference to

the importance of informed consent was met with indifference and represented a missed opportunity to discuss which risks were worth taking and who should make that decision. That summer, at a Gordon Conference on Nucleic Acids, it became clear that the technology, which would soon be dubbed Ògenetic engineering,Ó could indeed be realized.1 0 7

However, the issue of major

concern was not defined as the right to decide, but the uncertain possibility that moving DNA sequences from a known cancer-causing agent (SV-40 virus) to E. coli, a bacterium that is a ubiquitous inhabitant of animal and human intestines, might result in laboratory 106

Oxman, M.N., (1973). ÒPanel V - Common Sense in the Laboratory: Recommendations and Priorities, Comments by Conference OrganizersÓ. Conference: Biohazards in Biological Research: Proceedings of a conference held at Asilomar Conference Center, ("Asilomar I"), A. Hellman, M. N. Oxman and R. Pollack, Ed. Pacific Grove, CA, Cold Spring Harbor Laboratory. See p.347. 107 The Gordon Research Conference on Nucleic Acids took place on June 11-15, 1973, in New Hampton, New Hampshire. There are no published proceedings of Gordon Conferences. However, the meeting was mentioned in Singer, Maxine and Dieter Soll, (1973). ÒGuidelines for DNA Hybrid Molecules.Ó S c i e n c e. v. 181

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workersÕ becoming infected and theoretically increasing the incidence of cancer in the community.1 0 8 Maxine Singer and Dieter Soll, co-chairs of the Gordon Conference, sent a letter on behalf of scientists in attendance to Philip Handler, president of the National Academy of Sciences and to John R. Hogness, president of the National Institutes of Medicine.

The letter was also

published in the widely read journal, Science, on September 21, 1973.1 0 9 In it was expressed Òa matter of deep concernÓ over reports at the conference which described the technical ability to transfer gene sequences between organisms.

It continued, Ò[c]ertain ... hybrid

molecules may prove hazardous to laboratory workers and to the public.

Although no hazard has yet been established, prudence suggests

that the potential hazard be seriously considered.Ó1 1 0

In WrightÕs

account, Science editor, Philip Abelson is said to have questioned the wisdom of publishing the letter in such a public forum as Science. The decision to do so was made by a close majority vote of 48 to 42 of participants at that conference.1 1 1

The Singer/Soll letter also requested

that the National Academy of Sciences initiate a study to determine appropriate actions or guidelines for research with rDNA molecules.

(September 21) p. 1114. 108 Wright, Susan, (1994). Molecular Politics: Developing American and British Policy for Genetic Engineering, 1972-1982. Chicago, University of Chicago Press. See p.73. 109 Singer, Maxine and Dieter Soll, (1973). ÒGuidelines for DNA Hybrid Molecules.Ó S c i e n c e. v. 181 (September 21) p. 1114. 110 Ibid. 111 Wright, Susan, (1994). Molecular Politics: Developing American and British Policy for Genetic Engineering, 1972-1982. Chicago, University of Chicago Press. See p.136.

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The ÒBerg LetterÓ and Research Moratorium The next milestone, known as the ÒBerg letterÓ was also published as an open letter in Science on July 26, 1974.

The Berg letter was signed

by the most prominent researchers in the field of molecular biology in their capacity as members of a National Research Council Committee on Recombinant DNA.1 1 2

The committee had been convened as a direct

result of the Singer-Soll letter, described above.

The Berg letter asked

scientists to defer voluntarily from certain types of experiments Òuntil the potential hazards of such recombinant DNA molecules have been better evaluated or until adequate methods are developed to prevent their spread....Ó1 1 3 In addition to this unprecedented call for a self-imposed moratorium on certain types of biological research, the letter requested that the NIH Ògive immediate consideration to establishing an advisory committeeÓ for the purposes of devising guidelines and overseeing experimental programs.

It was also proposed that an international meeting should be

held to Òdiscuss appropriate ways to deal with potential biohazards of recombinant DNA molecules.Ó1 1 4 On October 7, 1974, in response to the requests and recommendations in the Berg letter, the NIH established the Recombinant DNA Molecule Program Advisory Committee, which was later renamed the Recombinant DNA Advisory Committee, or the

112

The National Research Council is part of the National Academy of Sciences. Berg, Paul, David Baltimore, Herbert W. Boyer, Stanley N. Cohen, et al., (1974). ÒPotential Biohazards of Recombinant DNA Molecules.Ó S c i e n c e. v. 185 (July 26) p. 303. 114 Ibid. 113

Chapter 3 ÒRACÓ.1 1 5


47

The RAC continued to play an important role throughout both

the Containment and Release Eras of the rDNA controversy.

Asilomar II The international meeting that was recommended by the Berg letter took place in February, 1975 at the Asilomar Conference Center (Asilomar II).

It was sponsored by the National Academy of Sciences,

and supported also by the NIH and NSF.

After three and a half grueling

days of mostly technical discussions, recommendations for physical and biological containment of rDNA organisms were compiled in the ÒSummary Statement of the Asilomar Conference on Recombinant DNA Molecules.Ó1 1 6 The emphasis at Asilomar II was on developing acceptable guidelines so that scientists could end the moratorium and resume their research. The meeting was never intended as a step toward public participation in scientific decision making.

In attendance were mostly molecular

biologists, plus a handful of lawyers and invited reporters, who were required not to recount what they heard until the conference was over. James Watson and John Tooze described the scientists as they left the Asilomar conference: Ò[They were] as exhilarated as they were exhausted. ... They had been praised ... for their social responsibility. ... They had voted to impose upon themselves special safety precautions. ... Having demonstrated their integrity, they

115

(39 FR 39306) Berg, Paul, David Baltimore, Sydney Brenner, Richard O. Roblin, et al., (1975). ÒAsilomar Conference on Recombinant DNA Molecules (Summary Statement of the Report Submitted to the Assembly of Life Sciences of the National Academy of Sciences).Ó S c i e n c e. v. 188 (July 26) p. 991. 116

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48

naively believed that they would now be free of outside intervention, supervision, and bureaucracy.Ó1 1 7 But a division of opinion regarding the significance of Asilomar had begun to form among scientists.

University of California, Berkeley

political scientist, Aaron Wildavsky noted, ÒLooking back on Asilomar a decade later, opinion among scientists was divided between those who saw statesmanship in calming the public and those who saw panic at imaginary fears.Ó1 1 8

NIH ÒGuidelinesÓ The NIH Recombinant DNA Molecule Program Advisory Committee (later the RAC) met the day after Asilomar II (February, 1975) to develop guidelines for the use of rDNA organisms in research, the first of which were issued on June 23, 1976 as ÒGuidelines for Research Involving Recombinant DNA MoleculesÓ (hereafter, simply ÒGuidelines.Ó)1 1 9

These Guidelines were to be followed by any

organization receiving NIH funding. A few months after the Guidelines were issued, a September 22, 1976 memo from President Gerald Ford to heads of all federal departments and agencies, expressed his expectation of Òfull cooperation [with the NIH] of each department and agency conducting or supporting recombinant DNA experiments.Ó1 2 0 117

Presidential ÒexpectationsÓ equate to

Watson, James D. and John Tooze, (1981). The DNA Story: A Documentary History of Gene Cloning. San Francisco, W. H. Freeman and Company. See p.26. 118 Wildavsky, Aaron, (1988). Goldilocks is Wrong: In regulation of biotechnology, only the extremes can be correct. preprint. Political Science. University of California. Berkeley, CA. See p.12. Tolin Archive, Box #43, with Brookings materials. 119 (41 FR 27902) 120 White House memorandum, dated September 22, 1976, from President Gerald Ford to Heads of relevant agencies. Tolin Archive, Box #4, Folder: FKN-111.

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49

Thus, by unofficial Executive Order, the NIH Guidelines were

effectively extended to all federally funded research in biotechnology. The original RAC Guidelines prohibited the deliberate release into the environment of any organisms which contained rDNA.1 2 1

Slightly

stricter than the recommendations in the Asilomar report, the focus was on physical and biological containment.

The first revision of the

Guidelines in 1978 retained the general prohibition on outdoor testing of rDNA organisms, but allowed for individual exemption waivers to be considered by the Director of NIH, under advice of the RAC and following notice of the proposal in the Federal Register to allow for public comment.1 2 2

By the 1982 revision, release of rDNA organisms

into the environment came under Section III-A-2, which required ÒRAC review and NIH and Institutional Biosafety Committee approval before initiation.Ó1 2 3

Frequent requests to modify the Guidelines were received

and published in the Federal Register for public comment.

Following

review of comments and open hearings if necessary, a decision would be made by the Director of the NIH. The strict prohibition on release of organisms containing rDNA into the environment conveniently soothed an anxious public so that medical research with rDNA could continue.

However, it created an enormous

problem for agriculture, for the obvious reason that the goal of most agricultural research is to develop a product or organism that will be used outdoors. 121

By announcing that rDNA should be carefully contained

(41 FR 27902). (43 FR 60080). 123 (47 FR 17180). See also Milewski, Elizabeth, PhD, (1985). ÒField Testing of Microorganisms Modified by Recombinant DNA Techniques: Applications, Issues, and Development of 'Points to Consider' Document.Ó Recombinant DNA Technical B u l l e t i n. v. 8 (3) pp. 102-108. See p.105. 122

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for safety reasons, NIH created the image of a tightly sealed PandoraÕs Box.

Later, when agriculture was ready for field testing, critics and

skeptics, including one powerful congressman, would hold up the NIHÕs original caution as reason to believe that rDNA was too dangerous to let loose before proper authority for regulation was in place.1 2 4

Integrity Backfires The 1974 call for a self-imposed moratorium on research resulted in rDNA technologyÕs introduction to the general public as Òscience that frightens scientists.Ó1 2 5

Some of the headlines following a National

Academy of Sciences (NAS) press conference announcing the letter read, ÒScientists Fear Release of BacteriaÓ (Los Angeles Times), ÒGenetic Scientists Seek Ban--World Health Peril FearedÓ (Philadelphia Bulletin), and ÒA New Fear: Building Vicious GermsÓ (Washington Star News).1 2 6 Understandably, some scientists must have felt violated.

They had

conscientiously publicized their concerns, some perhaps against their better judgment, and had unwittingly turned their own professional activities into a media circus.

ÒThere is no doubt that most molecular

biologists at first felt betrayed, like the person who is mugged by the old lady they have just helped cross the road.Ó1 2 7 124

By publicly airing

Letter from Representative John Dingell (D-MI) to NIH Director James B. Wyngaarden, September 26, 1983, questioning the wisdom of approving field release since the very reason for having the Guidelines was containment of rDNA. Tolin Archive, Box #3, F: Dingell/Kendrick '83-'84. 125 Bennett, William and Joel Gurin, (1977). ÒScience that Frightens Scientists: The debate over DNA.Ó The Atlantic Monthly. v. 239 (February) pp. 43-62. 126 Cited in Goodell, Rae, (1986). ÒHow to Kill a Controversy: The Case of Recombinant DNAÓ in Scientists and Journalists: Reporting Science as News. S. M. Friedman, S. Dunwoody and C. L. Rogers, Eds. New York. The Free Press/Macmillan. pp. 170-181. See p.172. 127 Lewin, Roger, (1991). ÒThe Asilomar Conference: Was the Asilomar Conference a Justified Response to the Advent of Recombinant DNA Technology, and Should It Serve as a Model for Whistle-Blowing in the Future?Ó in Bioscience « Society;

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their original concerns for safety of laboratory workers, the scientists opened a proverbial can of worms; then tried, unsuccessfully, to close it.

Scientists Divided In 1976, led by Senator Edward (Ted) Kennedy (D-MA), more than a dozen bills designed to control rDNA research were introduced in the Congress.1 2 8

As the issue polarized Capitol Hill, scientists divided

themselves on whether or not rDNA research should be regulated. Nobel Laureate, David Baltimore, called the Kennedy bill Òa clear invitation to begin the process of deciding what research shall be allowed and what research preventedÓ thus encroaching upon cherished academic freedom.1 2 9

During a 1980 Senate Hearing on Industrial

Applications of rDNA, Baltimore, one of the signers of the Berg letter and a member of the RAC, offered the following testimony: "In the six years since the [Berg] letter, all existing data has led to an increasing belief that the initial concern about hazard was unfounded ... I personally, do not believe that recombinant DNA represents any more hazard than other forms of research...."1 3 0 James Watson, another Nobel Laureate and signatory of the Berg letter, had decided by the mid-1970s that the danger factor ascribed to rDNA was Òan imaginary monster.Ó1 3 1

He expressed regret for having

Report of Schering Workshop. D. J. Roy, B. E. Wynne and R. W. Old, Eds. Chichester, NY. John Wiley & Sons. pp. 203-210. See p.206. 128 Ibid. 129 Culliton, Barbara J., (1978). ÒRecombinant DNA Bills Derailed: Congress still trying to Pass a Law.Ó S c i e n c e. v. 199 (20 January) pp. 274-277. See p.274. No citation was given; probably a reporterÕs quote. 130 U.S. Department of Health and Human Services, (1980). Recombinant DNA Technical Bulletin. NIH Publication No. 81-99. Washington, DC. November. See p.133. 131 Watson, James D., (1977). ÒAn Imaginary Monster.Ó Bulletin of the Atomic S c i e n t i s t s. v. 33 (May) p. 12+.

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signed the Berg letter.1 3 2

52

Likewise, Nobelist and Harvard biologist,

Walter Gilbert1 3 3 , in an open letter to Congress following the 1977 Gordon Conference on Nucleic Acids, which he chaired, wrote: ÒWe are concerned that the benefits of recombinant DNA research will be denied to society by unnecessarily restrictive legislation... We feel that much of the stimulus for this legislative activity derives from exaggeration of the hypothetical hazards of recombinant DNA research that go far beyond any reasoned assessment.1 3 4 The rhetoric in the Gilbert letter implied that the s a f e t y of rDNA was considered the only legitimate issue.

On the contrary, by no means

were all molecular biologists in agreement about safetyÕs being the only issue. For example, Erwin Chargaff,1 3 5 one of the pioneers of DNA research, framed his position ÒOn The Dangers Of Genetic MeddlingÓ in terms of an ethical problem rather than one of public health.1 3 6

He expressed a

belief that Ò[t]his world is given to us on loanÓ and that the Òfuture will 132

Watson expressed his regret in a speech quoted in McAuliffe, Sharon and Kathleen McAuliffe, (1981). Life For Sale. New York, Coward, McCann & Geoghegan. See p.176. Date of speech was not given. 133 Walter Gilbert was a co-recipient of the 1980 Nobel Prize in Chemistry. The prize was divided with half going to Gilbert and co-worker, Frederick Sanger, for determination of base sequences in nucleic acids. The other half of the Nobel went to Paul Berg for his work in recombinant DNA Nobel Prize Internet Archives, (date of posting not given). ÒNobel Prize in Chemistry Winners19961901Ó. Accessed October 19, 1998. 134 Quoted in Lewin, Roger, (1991). ÒThe Asilomar Conference: Was the Asilomar Conference a Justified Response to the Advent of Recombinant DNA Technology, and Should It Serve as a Model for Whistle-Blowing in the Future?Ó in B i o s c i e n c e « Society; Report of Schering Workshop. D. J. Roy, B. E. Wynne and R. W. Old, Eds. Chichester, NY. John Wiley & Sons. pp. 203-210. See p.206. 135 Erwin Chargaff played a significant role in molecular biology by showing that the molecular proportions of the nucleotide bases were constant. ÒChargaffÕs RuleÓ states that the proportions of cytosine are equal to those of guanine, and the proportions of thymine are equal to those of adenine in all samples of DNA studied. 136 Chargaff, Erwin, (1976). ÒOn the Dangers of Genetic Meddling.Ó S c i e n c e. v. 192

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curse usÓ for our Òdestructive colonial warfare against nature,Ó suggesting that his perspective on the world might have been very different from that of his fellow molecular biologists.1 3 7

Chargaff

advocated congressional action to intervene with a complete ban on the use of bacterial hosts that inhabit human organ systems (for example, E. coli) in rDNA research.

He urged the establishment of a licensing agency

for less objectionable work, which would only be carried out in one centralized facility, such as the one designed for biological warfare research at Fort Detrick in Maryland.

Chargaff was convinced that the

RAC was not equipped to deal with the issue. Chargaff was not the only one to lament that the RAC consisted Òalmost exclusively of advocates of this form of genetic experimentationÓ1 3 8

MIT molecular biologist Jonathan King accused the

RAC of being self serving, charging that the committeeÕs function was Òto protect geneticists, not the publicÓ and that putting Stanford UniversityÕs David Hogness in charge of it was like Òhaving the chairman of General Motors write the specifications for safety belts.Ó1 3 9 A collateral theme in the rDNA discussions was the notion that tampering with nature was inherently dangerous.

Chargaff asked,

ÒHave we the right to counteract, irreversibly, the evolutionary wisdom of millions of years, in order to satisfy the ambition and the curiosity of pp. 938-940. 137 Ibid. at p.940. 138 Ibid. at p.938. 139 King was quoted in McAuliffe, Sharon and Kathleen McAuliffe, (1981). Life For S a l e. New York, Coward, McCann & Geoghegan. See p.174.; (See also Bennett, William and Joel Gurin, (1977). ÒScience that Frightens Scientists: The debate over King was a DNA.Ó The Atlantic Monthly. v. 239 (February) pp. 43-62., at p.56-57.) prominent member of Science for the People and also a member of the Board of Directors for the Council for Responsible Genetics. (See Council for Responsible Genetics, (August 18, 1997). ÒProfiles of the Board of Directors and Key StaffÓ.

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a few scientists?Ó1 4 0

No doubt he included in that category of a Òfew

54

ambitious scientistsÓ James Watson, then director of the renowned Cold Spring Harbor Laboratory, with whom it is clear that Chargaff did not get along well personally.1 4 1 Erwin Chargaff was also not the only scientist who felt that the evolutionary wisdom of eons was best left alone.

Liebe Cavalieri, a

biochemist at Cornell University Graduate School of Medical Science and the Sloan Kettering Institute for Cancer Research, published a doomsday article about rDNA in which he predicted that scientists, bewitched by the desire for a Nobel Prize, would surely neglect their social responsibility and carelessly turn loose a cancer epidemic on an unsuspecting world.1 4 2

George Wald, a Nobel Laureate and member of

the Committee for Responsible Genetics (CRG), had also cautioned against tampering with the balance of nature.1 4 3

Wald described rDNA

technology as one that Òis all too big, and is happening too fast.Ó1 4 4 Finally, the politically radical group, Science for the People, which included molecular biologists, claimed that Òthe potential of science is not realized in a Ôsociety that puts profits before peopleÕ.Ó1 4 5 Science for CRG. Accessed December 30, 1998.) 140 Chargaff, Erwin, (1976). ÒOn the Dangers of Genetic Meddling.Ó S c i e n c e. v. 192 pp. 938-940. See p.940. 141 Watson, James D., (1980). The Double Helix: A Personal Account of the Discovery of the Structure of DNA. New York, Norton & Company. See p.78, p.168 142 Cavalieri, Liebe F., (1976). ÒNew Strains of Life--or Death.Ó New York Times M a g a z i n e. v. (August 22) p. 8+. 143 The Committee for Responsible Genetics (CRG), formerly the Coalition for Responsible Genetics and later renamed the Council for Responsible Genetics, is a very liberal group of scientists and non-scientists dedicated to public control of technology. Council for Responsible Genetics, (August 18, 1997). ÒProfiles of the Board of Directors and Key StaffÓ. CRG. Accessed December 30, 1998. 144 Wald, George, (1976). ÒThe Case Against Genetic Engineering.Ó The Sciences. v. 16 (September) p. 6+. 145 Maurer, C. and T.E. Sheets, Eds. (1999). Encyclopedia of Associations Detroit, MI,

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55

the People, which was not invited to send a representative to Asilomar II, sent an open letter to participants in the conference, denouncing rDNA research.1 4 6

Sheldon Krimsky, a member of the RAC and a

member of the CRG, also noted that members of the Green Party, which includes scientists, typically have very strong feelings about the notion of tampering with nature.1 4 7 These examples demonstrate that the rDNA debate was never simply one between scientists on the one hand and a scientifically illiterate public on the other.

The presence of knowledgeable scientists on both

sides of the debate indicates the wrong-headedness of the assumption that opposition to rDNA technology was rooted only in the fear of imaginary risks or the inability to understand the science involved.

It

also speaks to the futility of expecting science education alone to guarantee the acceptance of rDNA technology.

Having a science

education may have made it easier to read the literature, but probably played a lesser role than did individual world view in making choices regarding the appropriateness of rDNA technology. Although the agenda had been set at Asilomar as a safety issue, Jeremy Rifkin called the focus on safety Òa subterfuge to try and take away from the larger questions involved.Ó1 4 8 right.

On this detail, Rifkin was

Despite the superficial focus on safety throughout the

Gale Publishing. See p.770. 146 Watson, James D. and John Tooze, (1981). The DNA Story: A Documentary History of Gene Cloning. San Francisco, W. H. Freeman and Company. See p.27. 147 Krimsky, Sheldon, (1986). ÒThe Regulatory Quandry over BiotechnologyÓ. Conference: Proceeding of the 1986 Washington International Conference on B i o t e c h n o l o g y , Washington International Conference on Biotechnology, Ed. Washington, DC, Center for Energy and Environmental Management. See p.188. 148 Quoted in McAuliffe, Sharon and Kathleen McAuliffe, (1981). Life For Sale. New York, Coward, McCann & Geoghegan. See p.175.

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controversy, it was clear that there were also other motives for being either critical or supportive of rDNA research and that they played a role at least as important as concern for safety.

These motives were

most likely rooted in deeply held beliefs about how human society should behave, as I will demonstrate in the final chapter of this work.

Resolution Illusion? As long as rDNA organisms were carefully contained in research laboratories according to the NIH Guidelines, concern over the potential hazards of rDNA waned.

It appeared that Congressional legislation on

rDNA had begun to lose momentum by 1977.1 4 9

Goodell described a

curtailment period of the rDNA safety controversy (1977 to 1979) which occurred when Ònew dataÓ showed that rDNA was safe.1 5 0 These new data emerged from three meetings that had been held to evaluate the safety of rDNA organisms: one in Bethesda, MD, (1976), one in Falmouth, MA (1977), and one in Ascot, England (1978).1 5 1 The reliability of these Ònew data,Ó was itself surrounded by controversy. This subordinate debate in the rDNA controversy has been explored by others.1 5 2

149

For example, although the focus at the meetings was on

Lewin, Roger, (1991). ÒThe Asilomar Conference: Was the Asilomar Conference a Justified Response to the Advent of Recombinant DNA Technology, and Should It Serve as a Model for Whistle-Blowing in the Future?Ó in Bioscience « Society; Report of Schering Workshop. D. J. Roy, B. E. Wynne and R. W. Old, Eds. Chichester, NY. John Wiley & Sons. pp. 203-210. See p.206. 150 Goodell, Rae, (1986). ÒHow to Kill a Controversy: The Case of Recombinant DNAÓ in Scientists and Journalists: Reporting Science as News. S. M. Friedman, S. Dunwoody and C. L. Rogers, Eds. New York. The Free Press/Macmillan. pp. 170-181. 151 Wright, Susan, (1986). ÒMolecular Biology or Molecular Politics? The Production of Scientific Consensus on the Hazards of Recombinant DNA Technology.Ó Social Studies of Science. v. 16 pp. 593-620. 152 Newman, Stuart A., (1982). ÒThe ÔScientificÕ Selling of rDNA.Ó E n v i r o n m e n t. v. 24 (6) (July/August) pp. 21-23; 53-57.; Krimsky, Sheldon, (1982). G e n e t i c Alchemy: The Social History of the Recombinant DNA Controversy. Cambridge,

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enteric bacteria (primarily the laboratory strain of E. coli, K-12), conclusions of safety were extrapolated to other areas of research.1 5 3 Wright noted that, ÒThe persistent focus on the question of the conversion of E. coli, K 12 into an epidemic pathogen allowed other considerations to be factored out.Ó1 5 4 Wright argued that the real purpose of the meetings was to produce a scientific consensus that rDNA experimentation was safe so that research could continue.

She also alleged that the meetings were used

to political advantage to manipulate the direction of policy making.1 5 5 Wright and Goodell both point to lobbying efforts of political leaders of the scientific community who focused on the new data that showed rDNA was safe, which had the effect of marginalizing their critics.1 5 6 In addition, Krimsky refers to a shift of the burden of proof at this time from scientists (to show that it was safe) to the public (to show that it was dangerous).1 5 7

MA, MIT Press.; Wright, Susan, (1986). ÒMolecular Biology or Molecular Politics? The Production of Scientific Consensus on the Hazards of Recombinant DNA Technology.Ó Social Studies of Science. v. 16 pp. 593-620. 153 E. coli K-12 is a weakened laboratory strain of the bacterium that normally inhabits human (as well as other animalsÕ) gastrointestinal tracts. 154 Wright, Susan, (1986). ÒMolecular Biology or Molecular Politics? The Production of Scientific Consensus on the Hazards of Recombinant DNA Technology.Ó Social Studies of Science. v. 16 pp. 593-620. See p.616. 155 Ibid. 156 Goodell, Rae, (1986). ÒHow to Kill a Controversy: The Case of Recombinant DNAÓ in Scientists and Journalists: Reporting Science as News. S. M. Friedman, S. Dunwoody and C. L. Rogers, Eds. New York. The Free Press/Macmillan. pp. 170-181. See p.174; Also Wright, Susan, (1986). ÒMolecular Biology or Molecular Politics? The Production of Scientific Consensus on the Hazards of Recombinant DNA Technology.Ó Social Studies of Science. v. 16 pp. 593-620.. 157 Krimsky, Sheldon, (1986). ÒThe Regulatory Quandry over BiotechnologyÓ. Conference: Proceeding of the 1986 Washington International Conference on B i o t e c h n o l o g y , Washington International Conference on Biotechnology, Ed. Washington, DC, Center for Energy and Environmental Management. See p.179.

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Capitol Hill hesitated.

58

Whether or not the new data were reliable, the

reports had given the Congress an escape clause.1 5 8 Because safety had been successfully set as the definitive issue in the rDNA debate, lawmakers could turn from opposing the industry to supporting it and its potential for enhancing U.S. competitiveness instead.

At a National

Conference on Recombinant DNA and the Federal Government, Washington attorney Stephan Lawton summarized the reasons for loss of Congressional momentum during the late 1977 quiescent period regarding biotechnology. 1 . The consensus opinion regarding the safety of rDNA following the NIH Falmouth workshop indicated that hazard was extremely low. 2 . Scientists left their laboratories and came in droves to Capitol Hill in order to protect their interests. 3 . Uniform federal regulation was only preferable to a patchwork of local regulations; but regulation at the local level ÒdidnÕt happenÓ as was anticipated. 4 . The passage of time tempered doubts.1 5 9 In a 1977 letter to President Jimmy CarterÕs Director of the Office of Science and Technology Policy (OSTP), Dr. Frank Press, Senator Adlai Stevenson (D-IL),1 6 0 wrote: ÒI fear the regulatory procedures proposed in some of the pending legislation intrude excessively and needlessly on scientific freedom. ... I have come to the view that the

158

Culliton, Barbara J., (1978). ÒRecombinant DNA Bills Derailed: Congress still trying to Pass a Law.Ó S c i e n c e. v. 199 (20 January) pp. 274-277. See p.276; Goodell, Rae, (1986). ÒHow to Kill a Controversy: The Case of Recombinant DNAÓ in Scientists and Journalists: Reporting Science as News. S. M. Friedman, S. Dunwoody and C. L. Rogers, Eds. New York. The Free Press/Macmillan. pp. 170-181. See p.174. 159 Lawton, Stephan, (1981). ÒU.S.Congress on Recombinant DNA Research.Ó Recombinant DNA Technical Bulletin. v. 4 (2) (July) pp. 51-55. See p.54. 160 Stevenson was then Chairman of the Subcommittee on Science, Technology, and Space of the Senate Committee on Commerce, Science, and Transportation.

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arguments advanced initially for swift passage of recombinant DNA legislation are no longer persuasive.1 6 1 Framing it as a victory for science over the public, Wright claimed that by the end of the 1970s, the rDNA debate was essentially over. She wrote: ÒOne of the most remarkable aspects of the controversy about the hazards of recombinant DNA technology in the 1970s was the speed with which the whole issue faded away. Intensely debated in the period 1975-1977, by 1979 the hazard question was almost a non-issue.1 6 2 As Krimsky, Wright, and Goodell each pointed out, the apparent decline of concern about the hazards of rDNA in the late 1970s was due not only to the consensus announcement by the scientific community about objective new data showing that rDNA was safe, but also to subjective political forces such as lobbying efforts, marginalization of scientific researchers who criticized rDNA research, and pressure for the U.S. to prevail in international competitiveness.1 6 3 In GoodellÕs account, it was the journalists who lost interest in reporting on the Òdead issueÓ of biohazards.1 6 4

161

This should not be interpreted to mean, however, that

Letter from Senator Stevenson to Frank Press, dated September 7, 1977. Tolin Archive Box #1, Folder 5-1. 162 Wright, Susan, (1986). ÒMolecular Biology or Molecular Politics? The Production of Scientific Consensus on the Hazards of Recombinant DNA Technology.Ó Social Studies of Science. v. 16 pp. 593-620. See p.593. 163 Krimsky, Sheldon, (1982). Genetic Alchemy: The Social History of the Recombinant DNA Controversy. Cambridge, MA, MIT Press.; Goodell, Rae, (1986). ÒHow to Kill a Controversy: The Case of Recombinant DNAÓ in Scientists and Journalists: Reporting Science as News. S. M. Friedman, S. Dunwoody and C. L. Rogers, Eds. New York. The Free Press/Macmillan. pp. 170-181.; Wright, Susan, (1994). Molecular Politics: Developing American and British Policy for Genetic Engineering, 1972-1982. Chicago, University of Chicago Press. 164 Goodell, Rae, (1986). ÒHow to Kill a Controversy: The Case of Recombinant DNAÓ in Scientists and Journalists: Reporting Science as News. S. M. Friedman, S.

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the attention of a core group of interested individuals had been lost. The interested players, especially the critics of rDNA, had lost a valuable publicity partner when the media turned to other pursuits, but in the early 1980s, the groups consisting of rDNA supporters, rDNA critics, and science policy makers were still very much attentive to the negotiation of rDNA policy.

GoodellÕs observation of a reduction in media space

devoted to the issue may be taken only as an indicator of a possible lack of general public interest.

The i n t e r e s t e d public in this debate had

clearly not become inattentive as evidenced by the continued receipt by the RAC of letters from organizations critical of federal rDNA policy.1 6 5 With the acceptance of the NIH Guidelines, research had begun again, under what was effectively self-policing, relatively unnoticed by the general public.

Even non-federally funded organizations voluntarily

followed the containment Guidelines.

As more laboratory data were

collected it was determined that original fears about safety to humans had been exaggerated.

The NIH Guidelines were continually amended,

revised, and relaxed to allow more freedom for laboratory Dunwoody and C. L. Rogers, Eds. New York. The Free Press/Macmillan. pp. 170-181. See p.171. 165 I distinguish here between the ÒgeneralÓ public and the ÒinterestedÓ public. The ÒgeneralÓ public includes all American consumers. For the most part, these are people who are indifferent to science in general, until it is made relevant by an announcement of a breakthrough or a disaster. Whenever I refer to this group the word ÔpublicÕ will be qualified with the adjective Ôgeneral.Õ The ÒinterestedÓ public includes special interest groups, environmental groups, actively interested lawmakers and their staffs, financial investors, and individuals who believe that biotechnology will have an impact on society, one way or the other. Inclusion in the ÒinterestedÓ public assumes a relatively knowledgeable person or group who, either through a formal education or selfeducation, has at least a general understanding of what recombinant DNA is, what it can be used for, and what hazards it might represent. Members of this relatively small subset of our society have informed opinions about the technology and how it should be used or regulated. This is the ÔpublicÕ that makes its opinions heard and wishes to be included in decision making. Whenever the word ÔpublicÕ is used without qualification, it may be assumed that this is the

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experimentation with recombinant organisms and to give more responsibility to Institutional Biosafety Committees to ensure compliance with conditions that the RAC had established within the organizations where the research was being conducted.1 6 6

Summary In this chapter, I have presented rDNA policy highlights between 1973 and 1982 covering what I have called the ÒContainment EraÓ of the rDNA debate.

That era can be subdivided into several periods,

corresponding to FletcherÕs stages in the evolution of ethical debates.1 6 7 The beginning and ending dates of these periods are approximate, and overlap in some instances. A long gestation period came to an end in 1973, with the discovery of the means to transfer pieces of DNA from one organism to another of a different species.

While scientists paused to decide how to proceed,

the public was alerted by an unprecedented, self-imposed research moratorium (t h r esh o l d).

This expression of scientific uncertainty

provided a catalyst for conflict over control of the technology and threw the controversy into a crisis/ conflict

period.

The agenda for the debate

was set early as a safety issue and the focus was on preventing accidental release into the environment of organisms containing rDNA. The development of the RAC and research Guidelines represented an

subgroup to which I am referring. 166 For a summary of revisions to the NIH Guidelines see Milewski, Elizabeth, (1987). ÒThe NIH Guidelines and Field Testing of Genetically Engineered Plants and MicroorganismsÓ in Application of Biotechnology: Environmental and Policy I s s u e s. J. R. Fowle, III, Ed. Boulder, CO. Westview Press for the American Association for the Advancement of Science. pp. 55-90. 167 Fletcher, John C., (1990). ÒEvolution of Ethical Debate about Human Gene Therapy.Ó Human Gene Therapy. v. 1 (1) (Spring) pp. 55-68.

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attempt by the federal government to diminish the public crisis.

The

Guidelines were revised and relaxed as new safety data were obtained, which allowed the controversy to evolve slowly at the end of the decade into a quasi-quiescent period.

While a new Era was already gestating

(although no one would have know this at the time), researchers resumed their activities, relatively unnoticed, until the pattern repeated in the next cycle of debate, the ÒRelease Era.Ó In the four chapters that comprise Part II, I discuss the gestation, and t h r esh o l d periods of what I have dubbed the ÒRelease Era,Ó with special emphasis on the participation of the agricultural community. Any pause in the struggle for control was merely for a change in the scenery between acts.

Many of the same actors were there, still

clashing in the same roles. In Chapter Four, I reveal some of the research challenges faced by the agricultural community and the details of the quiet role that they played in the early revisions of the RAC Guidelines.

The forgotten

critics, who had lost their media partner, needed new fuel to rekindle general public interest. to take rDNA outside.

They got it when agricultural scientists wanted

PART II - LETTING THE GENIE OUT OF THE BOTTLE

ÒIn the 1970s, we were all trying to keep the genie in the bottle. Then in the 1980s, there was a switch to wanting to let the genie out. And everybody was wondering, ÔWill it be an evil genie?Õ

168

- Arnold Foudin, APHIS, USDA.

ÒNo single agency or entity presently has both the expertise and authority to properly evaluate the environmental implications of releases [of rDNA] from all sources.

169

- The ÒGore ReportÓ

ÒIt wouldnÕt be ÔfunÕ if we didnÕt fight and argue in public. Washington circus.

This was

170

- David Kingsbury, Chairman, BSCC

168

Interview with Arnold Foudin, Ph.D. Deputy Director Biotechnology Permits, PPQ, APHIS, USDA. Washington, DC (October 6, 1997). 169 U.S. Congress, House of Representatives, Committee on Science and Technology, Subcommittee on Investigations and Oversight, (1984). The Environmental Implications of Genetic Engineering (The "Gore Report"). U.S. Government Printing Office. Washington, D. C. February. Staff Report. Serial V. See p.10. Hereafter ÒThe Gore Report.Ó 170 Interview with David T. Kingsbury, Ph.D. former Assistant Director, Biological, Behavioral, and Social Sciences, National Science Foundation. Washington, DC (December 15, 1997). Kingsbury held this position from 1984 - 1988. He was also the chairman of the Biotechnology Science Coordinating Committee (BSCC) of the Domestic Policy Council Working Group on Biotecnology in the Reagan White House.

CHAPTER FOUR: GESTATION OF A NEW ERA IN THE rDNA DEBATE: 1977-1981 Introduction The period of quasi-quiescence at the end of the Containment Era was more likely a function of a short media attention span than of a total lack of activity on the rDNA front.

As media interest in reporting

on rDNA laboratory research issues waned, a new era in the rDNA controversy was already present in embryonic form. In this chapter, after acknowledging the issue of risk as it applied to the debate, I examine the obstacles that the agricultural community faced in promoting the revisions of the RAC Guidelines so that approval for release of rDNA organisms into the environment could be obtained. I also introduce the agricultural sub-communities that were most relevant to the negotiation of agricultural biotechnology and the relatively quiet, behind-the-scenes biotechnology policy activity during the gestation period of the Era of Release. Note that the gestation period of the Release Era, which overlapped the quasi-quiescent period of the Containment Era, coincided with the Administration of Democratic President Jimmy Carter, 1977-1981.

At

the same time, Democrats were in control of both houses of Congress.

Risky Business Releasing rDNA into the Environment: Benefits and Risks

There were many potential environmental applications for rDNA technology.

For example, rDNA organisms could have been useful in

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extraction and recovery of metals, clean up of oil spills, and breakdown of hazardous waste.

All the same, it was believed that agriculture

would be the biggest beneficiary of rDNA technology.

In 1984, then

Representative Albert H. Gore, Jr. (D-TN; later Vice President of the United States) wrote, ÒRecombinant DNA technology and other genetic engineering techniques will have a dramatic impact on all segments of society; nowhere will this impact be greater than in agriculture.Ó1 7 1 Goodell also acknowledged that ÒIt is in agriculture, ... that biotechnology will probably have its most important impacts.Ó1 7 2 Expectations were great.

It was postulated that by using

recombinant techniques, agricultural yields might be augmented through improved stress tolerance, disease and pest resistance, and improved nitrogen fixation capabilities.

It was envisioned that the

nutritional value of major grains (wheat, rice, corn) could be enriched by the addition of essential amino acids not normally present in those crops in large amounts.1 7 3

Recombinant techniques might also be

beneficial as a means of reducing reliance on agricultural chemicals through the use of microbial pesticides and herbicide resistant crop varieties.

In order to achieve these benefits, the rDNA organisms could

not be restricted to laboratory facilities because of the difficulties in

171

Gore, Albert H., Jr., (1984). ÒRecent Advances in the Plant Sciences: Applications to Agriculture and Agricultural ProductsÓ. Conference: U.S. Congress, House Committee on Science and Technology. 98th Congress, 2nd session. October., C. R. S. Report, Ed. Washington, DC, Letter of transmittal. 172 Goodell, Rae, (1986). ÒHow to Kill a Controversy: The Case of Recombinant DNAÓ in Scientists and Journalists: Reporting Science as News. S. M. Friedman, S. Dunwoody and C. L. Rogers, Eds. New York. The Free Press/Macmillan. pp. 170-181. See p.126. 173 Milewski, Elizabeth and Sue A. Tolin, (1984). ÒDevelopment of Guidelines for Field Testing of Plants Modified by Recombinant DNA Techniques.Ó R e c o m b i n a n t DNA Technical Bulletin (NIH). v. 7(3) (September) pp. 114-124.

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reproducing the many environmental conditions that they would have to face.

Outdoor testing would be obligatory.

There would be some risks, of course, defined mostly as lowprobability, high-consequence risks that something could go awry.

For

example, would it be possible that two harmless organisms, with attributes combined using rDNA techniques, might give rise to an exotic, deadly organism?1 7 4

Given the U.S. experience with the introduction of

exotic species such as Kudzu and the European Starling, could an experimental rDNA organism escape from an experimental field and multiply so rapidly as to become a pest itself?1 7 5 Aside from the possibility, however small, of immediate physical harm to humans or the environment, there were many other unanswered questions.

For example, would reliance on a few

commercial strains result in loss of genetic diversity?

Would farm

animals with additional extraneous genes suffer a poorer quality of life? Would the need to develop markets for rDNA products, in order to recover the high research and development costs, encourage the use of expensive, high-tech solutions to problems when low-tech, less expensive, less invasive, or less harmful systems would work just as well--or better? 174

Perhaps the biggest fear of rDNA did not derive from

For example, quoted in the Gore Report (see below) was a New Zealand study, Giles, K.L. and H.C.M. Whitehead, (1977). ÒReassociation of a Modified Mycorrhiza with the Host Plant Roots (Pinus radiata) and the Transfer of Acetylene Reduction Activity.Ó Plant and Soil. v. 48 pp. 143-152. The original conclusion that a pathogen could be created from two harmless organisms was refuted by Giles, Kenneth L. and Indra K. Vasil, (1980). ÒChapter 13: Nitrogen Fixation and Plant Tissue CultureÓ in International Review of Cytology, Supplement 11B, Academic Press. p. 81+. 175 For a list of arguments on both sides of the debate about risk in release of rDNA, Biotechnology: Agriculture's see U.S. General Accounting Office, (1986). Regulatory System Needs Clarification. GAO. Washington, DC. March. Report to the House Committee on Science and Technology. GAO/RCED-86-59.

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the science behind it, but from a specter of greed.

67 That is,

biotechnology might well exacerbate the difference between the haves and the have-nots.

The fear was that when the risks and benefits were

tallied, the many who assumed the risks might not include the few who reaped the benefits. Risk and The Importance of Choice

EPA Administrator, William Ruckleshaus, in a 1983 letter to Agriculture Secretary John Block wrote, ÒDespite substantial improvements in health care and longevity,

polls show that the public

believes that life is getting riskier, not safer.Ó1 7 6

However, the risks of

recombinant DNA, while rarely completely denied by scientists, were always supposed to be outweighed by the benefits.

For example, Henry

I. Miller, M.D. was a long term participant in RAC meetings as the liaison representative for the FDA. issue of rDNA risks.

He has published extensively about the

Miller has maintained that the benefits of rDNA

could be realized with a Òvanishingly smallÓ chance of catastrophic harm to humans or the environment.1 7 7

However, the benefits may not be so

great nor so within reach as was previously supposed.

Several of the

first transgenic fruits and vegetables were Ònotable commercial failures.Ó1 7 8

176

Even human gene therapy, despite all its promise, has yet

Letter dated September 21, 1983, regarding RuckleshausÕ coordinating effort for high level management of risk, public education about risk, risk assessment, etc. Tolin Archive, Box # 1 Folder 6-4. 177 Miller, Henry I., (1997). Policy Controversy in Biotechnology: An Insider's V i e w. Austin, R.G.Landes Co. See p.18. 178 Committee on Biotechnology, Division of Agriculture, NASULGC, (1996). Emerging Biotechnologies in Agriculture: Issues and Policies. National Association of State Universities and Land Grant Colleges. November. Progress Report. 15. See p.3.

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to produce a cure for any disease.1 7 9

68

These shortcomings in the

promises of biotechnology may bring the risks and benefits on to a more even playing field until the question really becomes, not one of relative risk to benefit ratios, but w h o risks and w h o benefits? The biotechnology debate was, and still is, about choice; who has it, who doesnÕt, and under what circumstances. the choices are often clear.

In medical circumstances

The affected person may decide to undergo

an unproven procedure, such as gene therapy.

The risks may be very

much higher than those of well tested, genetically modified tomatoes, but, if there is no other treatment available, the choice in this case may be between a possibility of cure on the one hand and certain death on the other. Agriculture faced a set of risks different from that faced by medicine.

Contrast the gene therapy scenario with one in which

consumers have a wide variety of choices regarding the food they eat. Why should they accept any risk whatsoever that may or may not be attached to genetically engineered tomatoes, or strawberries sprayed with genetically engineered microorganisms for frost protection, or milk produced by cows receiving extra doses of genetically engineered hormones, when they can choose to eat something else with which no one has tampered?

ÒToo many choices,Ó a luxurious situation that one

rarely experiences in medical decision making, may be the downfall of agricultural biotechnology.

179

Personal communication with Doris T. Zallen, Ph.D. Professor of Science Studies, Member of the NIH-RAC. Virginia Tech 1999). Also Langreth, Robert and Stephen D. Moore, (1999). ÒDelivery Shortfall: Gene Therapy, Touted as a Breakthrough, Bogs Down in Details.Ó Wall Street Journal. Eastern Edition. October 27, p. A1.

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When one is accustomed to having many choices, and one is then denied the ability to choose, trouble can be expected.

The public was

assured that the amount of rDNA introduced into an organism would be so small that there would be no perceptible difference between a recombinant organism and its non-recombinant cousins.

Unfortunately

for the agricultural community, this assurance had the opposite of its intended effect.

The inability to distinguish between recombinant and

non-recombinant products precludes the ability to make an informed choice between them.

In the case of an individual who is desperate for

a cure for a disease from which he or she is dying, an uninformed choice may be the only option, but in the case of a healthy individual choosing which foods to eat (for which there are many, many options), the knowledge that informed choice has been precluded may precipitate anxiety, fear, or anger.1 8 0

Although we might happily choose to buy

recombinant tomatoes that taste better, Ò[w]e are loath to let others do unto us what we happily do unto ourselves.Ó1 8 1 Risk-The Only EntrŽe into the Debate

On a scientific level at least, the focus of controversy during the Containment Era was on whether or not rDNA research could be done without hazard to laboratory personnel and without escape of rDNA organisms from confinement facilities.

180

In contrast, the rDNA debate of

For an array of considerations influencing safety judgments and an assessment of voluntary versus involuntary risk taking, see Lowrance, William W., (1976). Of Acceptable Risk: Science and the Determination of Safety. Los Altos, CA, William Kaufmann, Inc. 181 Chauncey Starr, National Academy of Engineering, ÒPerspectives on BenefitRisk Decision MakingÓ 30, (1972), cited from Lowrance, William W., (1976). Of Acceptable Risk: Science and the Determination of Safety. Los Altos, CA, William Kaufmann, Inc. See p.87. I have been unable to locate this original reference.

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the Release Era was focused on whether rDNA products should be allowed to leave the laboratory.

One thing remained the same.

Although releasing rDNA organisms into the environment brought with it many new arenas for debate (such as socioeconomic effects), the superficial emphasis of the controversy remained on scientifically answerable (at least theoretically) questions of physical or biological hazard.

For example, as pointed out earlier, Wright complained that,

ÒThe persistent focus on the question of the conversion of E. coli K-12 into an epidemic pathogen allowed other considerations to be factored out.Ó1 8 2 Because safety was still the dominant agenda item, and because science policy decisions regarding rDNA were required Òto be based on the best available science,Ó1 8 3 the undoing of those who focused exclusively on certain social questions was the inability to design a scientifically defensible test for them.

For example, throughout the

Release Era the question of determining whether or not the genetic engineering of new life forms constituted an affront to God was effectively invalidated by insisting that because policy had to be science-based, and because that particular question was not a scientifically answerable one, it must be disqualified from consideration. Those who might have preferred that rDNA technology not be pursued at all because of a belief that God might punish all of society for the audacity of a few would be denied legitimacy in the debate.

By

insisting that regulation must be science-based, critics of outdoor rDNA 182

Wright, Susan, (1986). ÒMolecular Biology or Molecular Politics? The Production of Scientific Consensus on the Hazards of Recombinant DNA Technology.Ó Social Studies of Science. v. 16 pp. 593-620. See p.616. 183 Language used in the proposed Coordinated Framework for regulation of rDNA,

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applications were effectively limited to health and environmental safety issues as the only entrŽe into the debate. Other concerns were simply dismissed by the dominant institutional structure of the federal government.

For example, when FDA affirmed

that a recombinant chymosin preparation1 8 4 had been assigned the status of ÒGenerally Recognized As Safe (GRAS),Ó the agency received two comments in response to the Federal Register announcement of February 1988.

Both comments questioned, not the safety of the

product, but the social n e e d for new sources of chymosin. The FDA dismissed these comments as irrelevant to their evaluation. ÒNeither comment contains any information relevant to the safety, functionality, environmental impact, or GRAS status of the food use of the subject chymosin preparation. Thus, the comments are not relevant to the agencyÕs evaluation of chymosin preparation. FDAÕs authority in reviewing...[such petitions] is limited to questions about the safety and functionality of the substance at issue and does not include questions about the need for a new food ingredient.Ó1 8 5 In general, risks can be objectively quantified and should continue to play a prominent role in policy formation.

However, the importance of

subjective value judgments and world views in the formation of science policy must not be discounted.

Although quantifying risk is a scientific

task which can be determined objectively by experts without public

December 31, 1984 (49 FR 50856) on p. 50904. 184 Chymosin preparation is a Pfizer product made from genetically modified bacteria for use in cheese making. Previously, chymosin was collected from the stomachs of slaughtered calves. 185 (55 FR 10932) Emphasis added.

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72

input, determining the degree of acceptable risk is a political process which expects the input of all those who will be affected.1 8 6

Prohibitions and Obstacles That Hindered Agricultural Biotechnology Impact of the NIH Guidelines1 8 7

If agriculture were to benefit from the new biotechnology, the ability to conduct outdoor experiments with rDNA would be essential. However, the NIH Guidelines, which were designed for conducting medical research with human pathogens, were not compatible with planned introduction of rDNA into the environment for agricultural purposes.

Deliberate outdoor release of any organisms containing rDNA

was expressly prohibited.

Most rDNA research, in order to comply with

the Guidelines, had to be conducted in physically contained settings designed to prevent the accidental escape of any organisms.

In effect,

the 1976 NIH Guidelines, which were by presidential mandate1 8 8 embraced by all federal agencies including the USDA, amounted to a prohibition on much of agricultural biotechnology research beyond the confines of a laboratory.

186

Keystone Center and National Biotechnology Forum, (1989). P u b l i c Participation and Education Summary Report and Recommendations. The Keystone Center. Keystone, CO. February. report. See p.2. 187 The original NIH Recombinant DNA Research Guidelines were issued on June 23, 1976, and published in the July 7, 1976 Federal Register. (41 FR 27902). 188 White House memo from Gerald R. Ford to the Heads of Departments and Agencies, dated September 22, 1976, mandating Òthe full cooperation of each department and agency conducting or supporting recombinant DNA experimentsÓ with the Secretary of Health, Education, and Welfare. Tolin Archive: Box #4, File: FKN-111.

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Some letters of comment on the original NIH Guidelines indicated that they were Òmore stringent than necessaryÓ but the writers Òsupported them as a compromise that would best serve the scientific community and the public at large.Ó1 8 9

Suzanne Huttner, Director of the

University of California Systemwide Biotechnology Research and Education Program, observed that some scientists had Òsupported scientifically flawed biosafety schemes they hoped would allow them to get on with their research, albeit more slowly and at greater cost.Ó 1 9 0 It was conceivable that the agricultural community might petition the NIH for a case-by-case exception, but they would have to be able to prove that the risk of hazard was negligible.

This placed agriculture in

a Catch 22: The rDNA products could not be tested outdoors without preliminary risk data, and there could be no risk data without testing outdoors because it is nearly impossible to reproduce all the variables in a laboratory or greenhouse.1 9 1

The same Guidelines that allowed

medical rDNA research to progress would be likely to hinder agricultural rDNA research unless changes were made.

Agriculture had

no process in place that would correspond to clinical trials as FDA had for biomedical products. Furthermore, the only research organism explicitly authorized by the first Guidelines was E. coli K-12. (One alternative host-vector system, Bacillus subtilis, a common soil inhabitant, was described in an appendix.) 189

While some laboratory work of an agricultural nature was

(41 FR 27902) at p. 27904. Huttner, Susanne, (1995). ÒGovernment, Researchers, and Activists: The Critical Public Policy InterfaceÓ in Legal, Economic, and Ethical Dimensions, Volume 12. D. Brauer, Ed. New York. VCH (J. Wiley and Sons). pp. 460-493. See p.467. 191 Personal communication with Sue A. Tolin, Ph.D. Professor of Plant Pathology, Physiology, and Weed Science, Former USDA representative to the NIH-RAC and 190

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carried out in E. coli K-12, more valuable organisms for plant researchers to use in rDNA work, for example the crown gall provoking A. tumefaciens that was studied by Smith and Townsend at the turn of the century, were not permissible according to the first published Guidelines.1 9 2 Release of Recombinant Agricultural Products Compared to Recombinant Medical Products

Genetically engineered medical products for the most part were expected to be extracted from living organisms and to be purified before leaving the laboratory.

(A notable exception was live-virus

vaccines, a very interesting issue in its own right which is outside the scope of this exposition.)

Once rDNA medical products were ready for

market, the Food and Drug Administration (FDA) would review and approve them based on the same rigorous criteria as those used to evaluate any other products.

Likewise, all food additives required pre-

market review and approval, regardless of the process by which they were made.1 9 3

As observed by Eric Flamm, an FDA senior policy advisor

in the Office of the Deputy Commissioner for Policy, in many cases, the Òproducts they were replacing were a lot riskier than the recombinant products, which often times were much cleaner.Ó1 9 4

OECD. Virginia Tech (various dates in 1998, 1999). 192 (41 FR 27902) 193 U.S. Department of Health and Human Services, (1981). Recombinant DNA Technical Bulletin. NIH Publication No. 81-99. Washington, DC. April. See pp.1516. 194 Interview with Eric Flamm, Ph.D. Senior Policy Advisor to the Deputy Commissioner for Policy, U.S. Food and Drug Administration. Rockville, MD (December 3, 1997).

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Recombinant products for agricultural applications, however, were especially problematic in terms of potential controversy.

Many of them

were obviously intended for eventual outdoor use as living entities (for example, seeds).

In some, though not all cases of agricultural

biotechnology, it was the goal of releasing rDNA organisms into the environment that they should survive and reproduce.

The mere

suggestion that rDNA should intentionally be spread into the environment, contained in live organisms capable of reproducing indefinitely, brought the safety issue to the forefront again.

Aside from

human health issues, one new environmental concern was that horizontal transfer of DNA might confer insect resistance, stress tolerance, or herbicide resistance on weedy relatives through cross pollination. Containment C o s t s

The containment facilities themselves, which were required by the Guidelines, presented another barrier to agriculture's ability to share in the benefits of biotechnology because of the considerable costs involved in building them.

In addition to federal support of medical research ,

which was relatively abundant and still increasing due to popular support of the war on cancer declared by President Richard M. Nixon in 1971, medical researchers had the financial backing of pharmaceutical firms, well-endowed medical schools, and humanitarian groups crusading for cures to specific diseases.1 9 5 195

On the other hand, funding

President Nixon had declared a federal Òwar on cancerÓ in 1971 Schmeck, Harold, Jr., (1971). ÒFund for Cancer: $100 Million Extra is Sought - Goals Set for Health Care.Ó New York Times. New York. January 23, p. 1. Nixon declared April, 1971, to be Cancer Control Month, at which time he requested Òan addition $100 million ... to press toward the conquest of cancer.Ó (36 FR 5899).

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for all agricultural research, not just for biotechnology, came primarily from the federal government.

Shirley Ingebritsen, Senior Regulatory

Specialist with USDA Animal and Plant Health Inspection Service (APHIS) Biotechnology Programs, offered the following evidence and explanation for disparate federal funding of medicine and agriculture. "Just look at the infrastructure that the government builds for doing its own in-house research. The NIH campus in Bethesda is a temple to human disease eradication while the USDA is working in crumbling old constructions in Beltsville. Consider also that the great increases in Congressional appropriations to the NIH, while [agricultural] funding stagnates, reflect a dramatic shift in U.S. demographics and economics from a rural, agricultural, producer society to an urban, consumer populace.Ó1 9 6 The great disparities in public funding of biotechnology for medical and agricultural applications continued into the Release Era.

Even

figures from the late 1980s put overall federal expenditures on basic biotechnology research at $2.7 billion, although only $150 million of that was earmarked for agricultural biotechnology research.1 9 7 The cost of conducting rDNA research, for the agricultural community in the 1970s, was almost prohibitive. In part because of issues discussed in this section, the progression of research, development, testing, and marketing for medical biotechnology was several years ahead of that for agricultural biotechnology.

Another factor contributing to medicineÕs lead is that

medical research was simultaneously being conducted by private 196

Interview #1 with Shirley Ingebritsen, Senior Regulatory Specialist, APHIS, USDA. Washington, DC (August 28, 1997). 197 Keystone Center and Environmental Citizen State and Local Leadership Initiative for Biotechnology, (1989). ÒWorkshop SummaryÓ. Conference: West

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pharmaceutical firms in addition to the research supported at public and private universities.

On the other hand, before the advent of

agricultural biotechnology, almost all basic research for industrial agriculture in the U.S. was publicly supported at what are known as Land Grant Colleges.

A brief background on the Land Grant System will

put this point in perspective.

Agricultural Academia and The Land Grant System The U.S. Department of Agriculture was founded in 1862, at a time when the U.S. was primarily a rural, agricultural, producer society.1 9 8 In the same year, President Abraham Lincoln signed the 1862 Morrill Act into law, creating a national Land Grant system.

The Morrill Act

authorized the states to sell public lands for the establishment of agricultural and mechanical colleges.

Later, the Hatch Act of 1887

authorized the placement of agricultural experiment stations at land grant colleges as well as formula funding for agricultural research projects.

The experiment stations were charged with conducting

Òoriginal and other research, investigations and experiments bearing directly on and contributing to the establishment and maintenance of a permanent and effective agricultural industry.Ó1 9 9

Finally, in 1914, the

Smith-Lever Act provided for the establishment of the Cooperative Extension Service which would extend the knowledge of the agricultural and mechanical colleges directly into the farming communities.

Two

Coast Regional Workshop, Tiburon, CA, The Keystone Center. See p.22. 198 Rossiter, Margaret W., (1979). ÒThe Organization of the Agricultural SciencesÓ in Organization of Knowledge in Modern America: 1860-1920. A. Oleson and J. Voss, Eds. Baltimore, MD. Johns Hopkins University Press. pp. 211-248. 199 Oklahoma Agricultural Experiment Station, (date of posting not given). ÒThe Hatch Act: 100 Years of ProgressÓ. Oklahoma State University.

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national level groups associated with the Land Grant System, which will be important to this history, are the National Association of State Universities and Land Grant Colleges, and the Cooperative State Research Service. The National Association of State Universities and Land Grant Colleges (NASULGC) represents the interests of public academic institutions of higher learning on the Washington scene.

The Committee

on Biotechnology (COB) of the Division of Agriculture of NASULGC was established in April 1982.

Among other duties, the COB was charged

with advising the Division on matters that would impact memberÕs ability to conduct research in biotechnology, for example, legislation.2 0 0 The COB published yearly progress reports under the series title ÒEmerging Biotechnologies in Agriculture: Issues and Policies,Ó beginning in 1982. The Cooperative State Research Service (CSRS) of the USDA was the federal coordinating agency for the State Agricultural Experiment Stations.2 0 1

CSRS also administered the Hatch formula funds and

competitive research grants, and provided coordinating assistance to agricultural researchers.

A major player in agricultural biotechnology

at the CSRS in the 1970s and 1980s was Senior Scientist John Fulkerson, a plant pathologist by training, often described by colleagues as a Òbrilliant man,Ó a Òtall timber among seedlings,Ó and a mentor to

Accessed November 25, 1998. 200 Committee on Biotechnology, Division of Agriculture, NASULGC, (1982). Emerging Biotechnologies in Agriculture: Issues and Policies. National Association of State Universities and Land Grant Colleges. November. Progress Report. 1. 201 During a recent USDA reorganization, CSRS became CSREES, the Cooperative State Research, Education, and Extension Service. For more information, see http://www.reeusda.gov/new/about/csreesa2.htm#mission .

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79

Fulkerson became very interested in the applications of

biotechnology to agriculture and was a major force in setting up the NASULGC Committee on Biotechnology. Fulkerson knew how to do business in and out of Washington, DC. With regard to research at U.S. agricultural experiment stations, he apparently knew everyone and everything.

His long-time colleague,

David MacKenzie said of Fulkerson, ÒHe was so plugged in, there was nothing going on anywhere in the country that he didnÕt know about.2 0 3 Known as an instigator who also knew how to get others to carry his ideas to fruition, Fulkerson recruited

Sue A. Tolin, a plant virologist

from Virginia Polytechnic Institute and State University (hereafter ÒVirginia TechÓ), as his protŽgŽe.

Eventually, what he knew, she knew.

Tolin became a key member of USDAÕs internal rDNA committees as well as a liaison member representing USDA to the RAC and to the international regulatory scene.

She was present at essentially all

meetings having to do with regulating agricultural biotechnology in the U.S. and was instrumental in influencing the direction taken by rDNA policy beginning in 1978 and continuing throughout the 1980s, the period covered by this dissertation.2 0 4

202

Interview with David MacKenzie, Ph.D. Executive Director, NE Regional Assn of State Agr. Experiment Stations, formerly with CSRS, USDA. Washington, DC (December 9, 1997). 203 Ibid. 204 Personal communication with Sue A. Tolin, Ph.D. Professor of Plant Pathology, Physiology, and Weed Science, Former USDA representative to the NIH-RAC and OECD. Virginia Tech (various dates in 1998, 1999).

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Initial USDA Involvement with rDNA Policy The first active participation of USDA with rDNA affairs appears to be in about 1975, when at the Interagency Plant Science Committee coordinated by the National Science Foundation (NSF), John Fulkerson (CSRS) discussed the views of Agriculture on the benefits and risks of applying biotechnology to food and fiber production.2 0 5

In January of

1976, Fulkerson was asked by the Department of Health, Education, and Welfare to suggest names of several people who were knowledgeable in both agriculture and rDNA.2 0 6

Fulkerson suggested, among others,

geneticist Peter Day, of the Connecticut State Agricultural Experiment Station, who was appointed to the RAC on July 1, 1976.

This

appointment was made just after the original NIH Recombinant DNA Research Guidelines were issued (June 23, 1976).2 0 7

Peter Day would

soon be in a position to advocate the interests of agricultural scientists at the NIH on several important matters. Agricultural

rDNA

Advisory

Committees

Internal to USDA, there were several sequential and overlapping Agriculture rDNA Committees.

Because these were internal

departmental panels, public records were not required, nor were they kept.

The papers of these committees exist only in personal archives of

participants and consist of documents such as meeting briefs or memos that mention happenings at the meetings.

From these documents, I

have determined the names and the approximate dates of the various 205

Anonymous handout dated 3-20-79, with the title: ÒHistorical Background of the Involvement of Agriculture in Recombinant DNA at the Federal Level.Ó Tolin Archive; Box #1, File 5-1. I have not investigated the proceedings of this meeting. 206 Ibid. 207 Ibid.

Chapter 4 USDA panels.


81

Often, many of the same individualsÕ names would appear

on membership lists from panel to panel.

Furthermore, it is clear that

people would often refer to any of these committees simply as the ÒUSDA rDNA Committee.Ó The various incarnations of the USDA rDNA Committee are: 1 . the ad hoc USDA rDNA committee (Fall 1976), 2 . the Agricultural Research Policy Advisory Committee (ARPAC) (April, 1977), 3 . the Joint Council Recombinant DNA Committee (JCRC; 1978), 4 . the Agriculture Recombinant DNA Advisory Committee (A-RAC), (1979 or 1980), and 5 . the Agriculture Recombinant DNA Research Committee (ARRC; 1984).2 0 8 Dates are approximate because there were considerable overlaps and reconstructions of the various committees.

In addition to the above

panels, in 1977 the Agricultural Research Service (ARS) and CSRS each also had their own independent panels.2 0 9

More work is needed to sort

out the histories of these individual committees, the actual time periods that they occupied, and their contributions to overall USDA rDNA policy.In the fall of 1976, an ad hoc USDA rDNA committee was formed

208

There are several relevant folders of materials in the Tolin Archive. They are, Box #1, Folders: 5-1 and 6-2 through 6-6; Box #2, Folder: 1979; Box #4, Folders: FKN111, FKN-114, and FKN-116. Particularly useful are the following: An anonymous handout entitled, ÒHistorical Background of the Involvement of Agriculture in Recombinant DNA at the Federal LevelÓ dated 3-20-79, (Box #1, Folder: 5-1) and a transcript of an early oral history made at a JCRC meeting (with the heading, ÒName now USDA RDNA CommitteeÓ) in Box #4 Folder: FKN-116. However, neither document is complete, and there are some discrepancies between the histories and other memos in the collection. 209 Memo from John Fulkerson, dated January 8, 1977, ÒSubject: Recomb. DNA Status/RecapÓ listed nine different committees relevant to agricultural rDNA. Tolin Archive, Box #3, Folder: 1978-1985 Important USDA Docs.

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to analyze the new RAC Guidelines.2 1 0

82

The committee endorsed the

original Guidelines in both their intent and philosophy, but recognized that they were too restrictive to allow Agriculture to benefit from the new technology.

This gave USDA an incentive to participate fully in the

revision of the RAC Guidelines.

Early in 1977, John Fulkerson was also

representing the USDA on the Federal Interagency Advisory Committee on rDNA, which formed a communication link among agencies at an administrative level.2 1 1 The activities of the USDA ad hoc committee were continued by the Agricultural Research Policy Advisory Committee (ARPAC), which was established on April 20, 1977 as a jointly sponsored effort by the USDA and the National Association of State Universities and Land Grant Colleges (NASULGC).2 1 2 The ARPAC/ad hoc members drafted a ÒNotice Regarding Research Involving Recombinant DNA Molecules,Ó with the intent that it would become USDAÕs official policy.

It specified

conditions for performing rDNA research to assure that both intramural 210

Anonymous handout dated 3-20-79 with the title: ÒHistorical Background of the Involvement of Agriculture in Recombinant DNA at the Federal Level,Ó Tolin Archive, Box #1, Folder: 5-1. 211 Ibid. 212 Memo from M. Rupert Cutler, Assistant Secretary, subject: DNA Research, dated April 20, 1977 indicates his suggestion that Òthe departmental committee continue.Ó It is possible that this meant he wished for the ad hoc committee to continue concurrently with the ARPAC. Also, a letter from Charles F. Lewis, Chairman of the USDA Recombinant DNA Committee, to Rupert Cutler, who was then USDA Assistant Secretary for Conservation, Research, and Education, dated September 15, 1977, refers to CutlerÕs memo having established the ARPAC on April 20, 1977. Both in Tolin Archive, Box #4, Folder: FKN-111. However, a third handwritten document addressed to Dr. Hugo Graumann, with an unidentified signature (dated April 26, 1978) refers to ARPAC and the ad hoc committee as one and the same, and calls it Òour j o i n t committeeÓ (emphasis added). Tolin Archive, Box #4, Folder: FKN-114. Finally, a fourth document refers a February, 1980 meeting of the JCRC as the ÒI n t e r a g e n c y Agricultural Recombinant DNA meetingÓ--not to be confused with the ÒFederal I n t e r a g e n c y Advisory CommitteeÓ on which John Fulkerson sat. Tolin Archive, Box #4, Folder: FKN-116. Emphasis added.

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and extramural agricultural research projects were following the Guidelines in the same prescribed way.2 1 3

At the same time, the ARPAC

recommended that a permanent Council (the Joint Council Recombinant DNA Committee - JCRC) be established to share responsibilities with the Committee (ARPAC) but that the Òcurrent USDA Recombinant DNA Committee [presumably the ad hoc committee] be dissolvedÓ in order to Òprevent overlapping of effort.Ó2 1 4 The JCRC, which was also jointly sponsored by USDA and NASULGC, took over the activities of the ad hoc committee in 1978.2 1 5

The first

meeting of the JCRC took place on November 17, 1978, at which the committee nominated Winston Brill and John Scandalios to serve as voting members of the RAC, and Sue Tolin as the non-voting liaison between USDA and the RAC.2 1 6

The initial membership of the JCRC

included State Agricultural Experiment Station representatives, such as Peter Day, and individuals from the research arm of the USDA, such as Clarence Grogan from the CSRS2 1 7 .

(See Appendix B for membership

list.) In 1980, the meeting minute titles changed from ÒJCRCÓ to ÒUSDA

213

Undated, unsigned document, entitled, ÒNotice Regarding Research Involving Recombinant DNA Molecules.Ó Tolin Archive, Box #4, Folder: FKN-114. Draft is stapled to a letter dated April 26, 1978. 214 Meeting minutes of March 22, 1978, ARPAC/Joint Council on Food and Agricultural Sciences. Tolin Archive, Box #4, Folder: FKN-114. 215 Memo from James Nielson to Ralph McCracken, dated December 27, 1979, documents that on August 22, 1978, JCRC took over from the ad hoc committee, then returned responsibility to USDA on July 12, 1979. Tolin Archive; Box #1, Folder 5-1. 216 Memo from C.O. Grogan, Chairman of the JCRC to Ned Bayley, dated November 17, 1978. Tolin Archive, Box #4, Folder: FKN-114. 217 List attached to letter from James Nielson, Executive Director, Joint Council on Food and Agricultural Sciences, to Members of [Agricultural] Recombinant DNA Committee, dated October 10, 1978. Tolin Archive, Box #4, Folder: FKN-114.

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RDNA CommitteeÓ where upon people began calling it the ÒA-RAC.Ó2 1 8 A-RAC is the term I will use throughout most of this dissertation. Clarence O. Grogan, a USDA agronomist from CSRS, was named the Agriculture Recombinant DNA Research Officer and chaired both the JCRC and the succeeding A-RAC. As the Recombinant DNA Research Officer, GroganÕs responsibilities included maintaining a registry of USDA funded research involving rDNA, coordinating independent evaluation of the containment levels required for the research, and maintaining communication with the RAC, principal investigators, and local institutional biosafety committees. The JCRC membership included (among others--see Appendix B) Sue A. Tolin, who was representing both CSRS and the Land Grant Universities as a faculty member from Virginia Tech, Robert Kahn from the regulatory division (APHIS), Mary Clutter, Program Director for Developmental Biology from the NSF, and William Gartland, the Director of the NIH Office of Recombinant DNA Activities (ORDA)--the administrative home of the RAC.2 1 9

Gartland, representing the NIH,

attended all meetings as a liaison to USDA in the same manner as did Tolin, representing USDA at the RAC.

Thus there was early and

continuous communication between USDA and the other agencies on the scientific level. It was at one of the JCRC meetings that the representative from the Animal and Plant Health Inspection Service (APHIS) Veterinary Services division casually mentioned a proposal they had received to 218

The last available meeting minutes of the JCRC (also called the ÒInteragency Agricultural Recombinant DNA meetingÓ) was dated February 20, 1980. By May 22, 1980, the minutes were titled ÒUSDA-RDNA Committee meeting.Ó Tolin Archive, Box #4, FKN-116.

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remove parts of genes from the highly contagious virus which causes Foot and Mouth Disease (FMD) from the high containment animal disease research facility on Plum Island,2 2 0 and using rDNA technology, insert the genes into another organism for research to be done by Genentech, Inc., a biotech firm in California.

Sue Tolin recalled, ÒI

looked at Bill [Gartland] and he looked at me, and we said, ÔWait a minute--thatÕs a Class 5 organism. RACÕ.Ó2 2 1

This proposal has to go through the

The USDA, which was little accustomed to outsider interest in

what they were doing, had hardly expected this requirement for outside supervision. The RAC discussed the Plum Island-Genentech proposal at their December 6-7, 1979 meeting, and decided it would grant permission, in phases, to allow the development of a vaccine, provided that the Òcollection of clones to be shipped from Plum Island [did] not contain among them, collectively or individually, the full genome of the FMD

219

List from Tolin Archive, Box #2, Folder 1979. The Plum Island Animal Disease Center (PIADC), an isolated research facility located off the coast of Long Island, New York, was the only location where FMD research (as well as research on other exotic diseases of domestic animals) was conducted (see 21 U.S.C.113a). 221 Classification system is the one used by the U.S. Centers for Disease Control, U.S. Public Health Service, Atlanta, Georgia. Use of rDNA derived from Classes 3, 4, and 5 (5 is the most deadly or exotic) organisms were prohibited by the Guidelines (41 FR 27902) at p.27907. National Institutes of Health. (1976). ÒRecombinant DNA Research Guidelines.Ó Federal Register v. 41: 27902-27943. July 7. Also, Personal communication with Sue A. Tolin, Ph.D. Professor of Plant Pathology, Physiology, and Weed Science, Former USDA representative to the NIH-RAC and OECD. Virginia Tech (various dates in 1998, 1999). The conversation recalled by Tolin possibly took place at an October 10, 1979 meeting of the JCRC. Handwritten notes taken at that meeting show ÒPlum Island--Gartland will contact.Ó Tolin Archive, Box #2, Folder: JCRC 1979. A Memo of Understanding for the FMD Virus project, dated September, 1979, was included in the same folder. Meeting minutes for October 10 are not immediately available. Minutes of the September 17, 1979 JCRC meeting indicated that Plum Island had already contacted Dr. Grogan regarding the organization of a local institutional biosafety committee. Tolin Archive, Box #4, Folder: FKN-115. 220

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86

Thus, Genentech was permitted to remove only non-infective

parts of the viral genome from Plum Island and take them to their San Francisco laboratory.

The FMD virus became the first Class 5 organism

to receive RAC approval.2 2 3 FMD virus was a veterinary pathogen, not human, but technically still well within RACÕs purview without a major change in the Containment Era paradigm.

In 1981, an addition to Appendix E of the

Guidelines announced the specific approval of work with this pathogen.2 2 4

Although the status of live recombinant vaccines was

debated as a Òrelease into the environmentÓ issue, field trials for agricultural and environmental applications were carefully segregated in meaning and in regulatory consideration from clinical trials for either human or veterinary medicine.2 2 5

Challenging Prohibition The Meeting at Airlie House - April, 1977

On April 12 and 13 of 1977, fifteen plant and animal scientists met at the Airlie House Conference Center just outside of Washington, DC, to discuss the suitability of the NIH Guidelines for guiding research in non-

222

RAC meeting minutes, December 6-7, 1979. For a brief review of the progress made by the Foot and Mouth Disease Virus vaccine during this period, see U.S. Department of Health and Human Services, (1980). Recombinant DNA Technical B u l l e t i n. NIH Publication No. 80-99. Washington, DC. August. See p.27. 223 Tolin, Sue A., (1981). ÒThe Role of USDA Quarantine Regulations and Culture Collectins in Recombinant DNA Research (reprint of ASM Seminar).Ó Recombinant DNA Technical Bulletin. v. 4 (4) (December) pp. 156-159. See p.159. 224 U.S. Department of Health and Human Services, (1981). Recombinant DNA Technical Bulletin. NIH Publication No. 81-99. Washington, DC. Sepember. See p. 127. 225 Personal communication with Sue A. Tolin, Ph.D. Professor of Plant Pathology, Physiology, and Weed Science, Former USDA representative to the NIH-RAC and OECD. Virginia Tech (various dates in 1998, 1999).

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medical, primarily agricultural, applications.2 2 6

87

The workshop on

recombinant DNA molecule research was co-sponsored by USDA and the National Science Foundation (NSF).

The workshop chairman was Peter

Day, the agricultural communityÕs first representative to the RAC.

Day

wrote a letter summarizing the results of the meeting to John W. Littlefield of Johns Hopkins Hospital, then Chairman of the RAC Subcommittee on Revisions to the Guidelines.2 2 7 Peter Day reported to Littlefield that the NIH prohibition on release of rDNA into the environment was the biggest hurdle to agricultural researchers' being able to take advantage of the new biotechnologies. By 1977, plant scientists had already been using rDNA techniques in their research laboratories and it was anticipated that animal scientists would also wish to use such techniques in the near future.

However,

many research ideas and products would be useless unless they could be tested outdoors. DayÕs letter specified several recommendations to address this problem. 1 . Other non-medical personnel, as well as agricultural scientists, should have representation on the RAC to facilitate revisions to the Guidelines that would allow agricultural research to progress. 2 . A classification system for pests and pathogens of plants and animals should be developed on the basis of their hazard to agriculture. The containment levels prescribed by the Guidelines were based on the potential pathogenicity of rDNA organisms only to h u m a n s. 226

The Airlie House Conference Center, located in Warrenton, Virginia, is an intellectual retreat on a large campus that includes a working farm and a nature preserve. (http://www.abanet.org/publicserv/airlie/house.html) 227 Letter from Peter Day to John W. Littlefield, Chairman of the NIH rDNA Molecule Program Advisory Committee, dated April 14, 1977. Tolin Archive, Box #1, Folder: 2-1

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3 . The letter asked for a means of assessing environmental impact possibilities in advance of allowing release of rDNA into the environment. In effect, the Day letter was advising the NIH that agricultural research would soon be to the point where it would be ready for outdoor testing. Would the NIH be prepared to review and approve such protocols? Agricultural Risk Assessment and The Chilton Proposal

Although the USDA had agreed to require compliance with the Guidelines as a condition of funding its grantees, the agency recognized that the researchers it supported through the experiment stations would eventually want to challenge the prohibition against deliberate environmental release of rDNA organisms.2 2 8

On March 20-21, 1978 a

group of plant scientists met in Washington, DC, to discuss containment conditions necessary for working with rDNA in plants.

It was the

consensus of this group that Òworking with plant pathogens and baculoviruses in recombinant DNA studies presents no more hazard than that which exists in current laboratory studies with the pathogens themselves.Ó2 2 9

This consensus was substantiated by the absence of any

conclusive evidence of any serious problems with the parent pathogens after many years of experience in working with them in the past.2 3 0 228

Tolin, Sue A. and Anne K. Vidaver, (1989). ÒGuidelines and Regulations for Research with Genetically Modified Organisms: A View From Academe.Ó A n n u a l Review Phytopathology. v. 27 pp. 551-81. See p.561. Also, numerous documents, circa 1977, indicate USDA dissatisfaction with RAC GuidelinesÕ prohibition of environmental release. Tolin Archive, Box #1, Folder 5-1. 229 Workshop conducted by the RAC, and sponsored by USDA, NSF, and NIH. (43 FR 33042) See p.33174. Appendix G: Report of workshop on risk assessment of agricultural pathogens. 230 Twenty years later, there have still been no problems reported from working with rDNA agricultural pathogens, so the consensus appears, in retrospect, to have been correct.

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However, given that no rDNA risk assessment studies had yet been permitted with plants under the Guidelines, it certainly

raised some

eyebrows when scientists were willing to extrapolate from a lack of problems with ÒAÓ to there being no anticipated problems with ÒA+BÓ even before ÒA+BÓ had been tested.

Nevertheless, there was a steadfast

presupposition on the part of some molecular biologists that rDNA created nothing new or extraordinary, and that rDNA organisms were no more dangerous than the parent organisms from which they were derived.2 3 1 Agriculture needed risk data.

In April of 1978, Mary-Dell Chilton

and her colleagues at the University of Washington, wrote a letter to Mary Clutter at the National Science Foundation (NSF) outlining a research experiment to assess risks and benefits of using Agrobacterium tumefaciens and its Ti plasmid.2 3 2

Chilton and her

colleagues had recently demonstrated that the mechanism of pathogenicity of A. tumefaciens, (the same organism whose tumorinducing characteristics were described by Smith and Townsend at the turn of the century, see Chapter Two), was by insertion of a portion of the Ti plasmid into the plant chromosome.

Chilton et al. noted as

apparent Òthe potential applications of this transmissible element of the virulence plasmid as a vector in future genetic engineering studies in

231

David MacKenzie, former director of the National Biological Impact Assessment Program, which was designed to assess risk of field tests, indicated his disbelief that scientists were willing to make such statements before doing the testing. Interview with David MacKenzie, Ph.D. Executive Director, NE Regional Assn of State Agr. Experiment Stations, formerly with CSRS, USDA. Washington, DC (December 9, 1997). 232 Letter from Mary-Dell Chilton and colleagues to Mary Clutter, NSF, dated April 19, 1978. Tolin Archive, Box #2, Folder: 1978. (A plasmid is defined in a Chapter Two footnote.)

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higher plants.Ó2 3 3

90

Hitherto, no one had used the Ti plasmid as a vector

to insert a foreign gene into a plant genome because the Guidelines would not permit the use of rDNA methods to put the foreign gene into the plasmid.

Clutter shared the letter with agricultural scientists, John

Fulkerson and Peter Day, as well as with Sue Tolin when she entered the scene in June of 1978.2 3 4 As a member of the RAC, Day knew that the Guidelines were about to undergo another revision.

Although he knew that the recommendations

of the March, 1978 workshop on risk assessment of agricultural pathogens had been favorably received by the RAC, there was no assurance that these recommendations would be adopted into the Guidelines in a form agreeable to agricultural researchers.

In a May 10,

1978 letter, Day forwarded a copy of the Chilton et al. proposal to high ranking officials at USDA, NSF, and NIH, asserting that the experiments outlined in this proposal were too important to wait until the revised Guidelines came out.

Day asked for the RAC to consider granting an

immediate exception.2 3 5

Day then initiated a concerted effort to push

for approval for the A. tumefaciens work to be done at a high level containment facility in Frederick, Maryland, before the revised Guidelines became official. 233

A flurry of letters and notes ensued on this

Chilton, Mary-Dell, Martin Drummond, Donald J. Merlo, Daniela Sciaky, et al., (1977). ÒStable Incorporation of Plasmid DNA into Higher Plant Cells: the Molecular Basis of Crown Gall Tumorigenesis.Ó Cell. v. 11 (June) pp. 263-271. Chilton et al. also viewed crown gall tumors as a Òfeat of genetic engineeringÓ with an Òimportant etiological similarity [to] animal cancers (at p.268).Ó 234 Personal communication with Sue A. Tolin, Ph.D. Professor of Plant Pathology, Physiology, and Weed Science, Former USDA representative to the NIH-RAC and OECD. Virginia Tech (various dates in 1998, 1999). 235 Letter from Peter Day to James Nielson, Acting Director of USDAÕs Science and Education division (which included CSRS), NSF Director Richard C. Atkinson, and NIH Director Donald Fredrickson, and with copies to several other key rDNA advisory personnel. Tolin Archive, Box #2, Folder: 1978.

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topic between and among rDNA policy personnel in several federal agencies. For example, NIH Director Donald Fredrickson received pressure from James Nielson, USDAÕs Science and Education division Acting Director, for a response to DayÕ request.2 3 6

On July 27, the day before the release

of the newly proposed Guidelines, Fredrickson declined the USDA request for immediate attention to the Chilton proposal before the Guidelines were revised, but promised that it could be considered if the new revisions passed. The hesitancy of the NIH director to approve the Chilton proposal at that particular time and place (the high containment facility in Frederick, Maryland) was perhaps a consequence of troublesome civil action suits that had been filed the previous year.

In one of them, trial

attorney, Ferdinand Mack, had sought an injunction against the NIH for a previous risk assessment experiment to be done at Fort Detrick in Frederick, Maryland, involving a polyoma virus.2 3 7

Use of material from

the polyoma virus was in the prohibited category of rDNA experiments, but the RAC voted to make an exception because of the crucial need for risk assessment data.2 3 8

236

Although the NIH prevailed when the case was

Among the letters was one from James Nielson, Acting Director of USDAÕs Science and Education division, to Donald Fredrickson, NIH Director, dated June 29, 1978. Tolin archive; Box #2, Folder 1978, contains this and other letters pertaining to this topic. 237 F.J. Mack, Jr. v. J.A. Califano, Jr. et al., Civil Action #77-916, U.S. District Court, District of Columbia. Filed May, 1977. Decided February 23, 1978. Also, Telephone interview with Ferdinand Mack, JD. trial attorney, Frederick, MD (November 29, 1998).. Polyoma virus is similar to the monkey virus, SV-40, except it infects mice, not monkeys. Old, R.W. and S.B. Primrose, (1985). Principles of Gene Manipulation: An Introduction to Genetic Engineering. Boston, Blackwell Scientific Publications. See p. 251. 238 Krimsky, Sheldon, (1982). Genetic Alchemy: The Social History of the Recombinant DNA Controversy. Cambridge, MA, MIT Press. See p.246.

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decided, it was no doubt sufficiently disturbing to the agency that caution was warranted when facing a similar case.2 3 9 Anson R. Bertrand, the new USDA Science and Education Director, upon seeing NIH Director FredricksonÕs response to Nielson regarding Peter DayÕs request for an exception, challenged Fredrickson in a letter of August 15, 1978 by citing a precedent.

Fredrickson had recently

allowed an exception to the Guidelines for the purpose of cloning in yeast at the request of NSF for a project they had funded.2 4 0

Bertrand

claimed that the yeast experiment was similar to ChiltonÕs, yet ChiltonÕs had been denied.

Bertrand reiterated the USDAÕs strong feelings about

beginning the risk/benefit assessment experiments at the high containment facilities in Frederick, Maryland, without further delay.

He

also criticized the Òextremely restrictive 1976 Guidelines [which had] already impeded the application of recombinant DNA technology to [U.S. agriculture] for 2 years.Ó2 4 1

Tolin recalled drafting this letter with

Fulkerson and Clutter.2 4 2 The USDA, having had no assurance from NIH that the Chilton experiment would ever be allowed, wanted to push the issue immediately.

Agriculture was still in a Catch 22:

They could not test

rDNA products without preliminary risk data, and there could be no risk data without testing. 239

The Chilton experiment, although not an

F.J. Mack, Jr. v. J.A. Califano, Jr. et al., Civil Action #77-916, U.S. District Court, District of Columbia. Filed May, 1977. Decided February 1978. 240 Personal communication with Sue A. Tolin, Ph.D. Professor of Plant Pathology, Physiology, and Weed Science, Former USDA representative to the NIH-RAC and OECD. Virginia Tech (various dates in 1998, 1999). 241 Letter from Anson R. Bertrand, USDA Director of Science and Education, to Donald Fredrickson, Director, NIH, dated August 15, 1978. Tolin Archive, Box #2, Folder: 1978.

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environmental release, would have yielded valuable risk information about gene transfer.

For the time being, however, it would have to wait.

Expanding Federal Oversight

The July 28, 1978 Federal Register announcement of proposed revisions to the Guidelines had incorporated the report of the March 2021, 1978 Workshop on Agricultural Pathogens,2 4 3 and had also taken into account Òall major suggestions for revision that were made to NIH as a result of the [1977] Airlie House meeting.Ó2 4 4 NIH Director Fredrickson also acknowledged the importance to agriculture of the eventual ability to release rDNA organisms into the environment, and at the same time acknowledged the need for the Òdeep involvementÓ of the USDA, Ògiven the limited experience of NIH in agricultural research.Ó2 4 5 Five months later, on December 22, 1978, the revised Guidelines were published.

The revision retained prohibition section I-D-4 which

banned deliberate release into the environment of any organism containing recombinant DNA.2 4 6

However, provision was then included

for a case-by-case consideration by the RAC for exceptions.

In the

accompanying decision document, NIH Director Fredrickson acknowledged that several comments had been received from members of the agricultural community urging that mechanisms be set in place

242

Personal communication with Sue A. Tolin, Ph.D. Professor of Plant Pathology, Physiology, and Weed Science, Former USDA representative to the NIH-RAC and OECD. Virginia Tech (various dates in 1998, 1999). 243 (43 FR 33042) See p. 33175. 244 Letter from Peter Day and Milton Zaitlin (Cornell University Department of Plant Pathology) to Acting Assistant Administrator of Science and Education Administration, USDA, dated August 8, 1978. Tolin archive; Box #2, Folder 1978. 245 (43 FR 33042). See p.33051. 246 (43 FR 60108).

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94

Fredrickson asked the RAC to address conditions under

which exceptions to Section I-D-4 could be granted.2 4 7 Department of Health, Education, and Welfare (HEW) Secretary Joseph Califano had, in the same document, also requested formulation of Òa plan for carrying out a balanced program of ... risk assessment experimentsÓ in order to determine whether the Guidelines Òafford appropriate protection for health and the environment.Ó2 4 8

Mary-Dell

Chilton presented her proposed risk assessment experiment to a meeting of the RAC in May of 1979.2 4 9

After some deliberation, the

Chilton et al. proposal using A. tumefaciens was finally approved by the NIH in the summer of 1979 under moderately high containment conditions.2 5 0 Enter EPA and FDA

Also in the December 22, 1978 decision document, HEW Secretary Califano had authorized expansion of RAC membership, as requested by the participants at the Airlie House meeting, Òto include persons knowledgeable in a wide variety of fields such as law, public policy, ethics, the environment, and public health.Ó2 5 1

Furthermore, he

expressed the intent to extend the reach of the Guidelines beyond 247

(43 FR 60080). See p.60083. Ibid. See p.60082. 249 RAC minutes, May 21-23, 1979, in U.S. Department of Health and Human Services, (1980). Documents Relating to "NIH Guidelines for Research Involving Recombinant DNA Molecules" January 1979 - January 1980, Office of Recombinant DNA Activities, NIH Publication No. 80-2130. See p.101. 250 RAC minutes, May 21-23, 1979 in U.S. Department of Health and Human Services, (1980). Documents Relating to "NIH Guidelines for Research Involving Recombinant DNA Molecules" January 1979 - January 1980, Office of Recombinant DNA Activities, NIH Publication No. 80-2130. See p.101. Also U.S. Department of Health Education and Welfare, (1979). Recombinant DNA Technical Bulletin. NIH Publication No. 80-99. Washington, DC. November. See p.115-116. 251 (43 FR 60080) See p.60081. 248

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federally funded research to the private sector through cooperation with the Food and Drug Administration and the Environmental Protection Agency (EPA).

The notice read,

ÒIf both FDA and EPA act to regulate privately conducted recombinant DNA research, virtually all recombinant DNA research in this country would be brought under the requirements of the revised guidelines.Ó2 5 2 At the direction of the HEW Secretary, the FDA had immediately, in the same December issue of the Federal Register, set in place de facto regulation of rDNA in the private sector by requiring all submissions to comply with the NIH Guidelines.2 5 3 Califano had asked EPA Administrator, Douglas Costle,2 5 4 to review EPAÕs regulatory authorities to determine whether EPA could regulate private rDNA research that did not come under the purview of the FDA, and Òto take all action he can.Ó2 5 5

Costle was no doubt eager to take

seriously CalifanoÕs suggestion that the EPA should begin regulating rDNA, because he had expressed the view that that both the original and the revised NIH guidelines were Òdeficient with respect to protection of the environment.Ó2 5 6 252

Ibid. See also HEW News press release, ÒStatement by Joseph A. Califano, Jr. Secretary of HEWÓ dated December 17, 1978, page 9. Tolin Archive, Box #4 Folder: FKN-114. 253 (43 FR 60134) 254 Costle was instrumental in the development of the EPA in 1970. As an active Democrat, Costle was disappointed when Republican President Nixon did not reward him for his efforts by appointing him as the first Assistant Administrator. Democratic President, Jimmy Carter, appointed Costle EPA Administrator in 1977 Current Biography Yearbook 1980. (1981). Moritz, Charles, ed. ÒDouglas M. CostleÓ. The H.W. Wilson Company. New York. See p.55-58. 255 HEW News press release, ÒStatement by Joseph A. Califano, Jr. Secretary of HEWÓ dated December 17, 1978, page 8. Tolin Archive, Box #4 Folder: FKN-114. 256 EPA Administrator's Statement in the matter of the Proposed Guidelines for the Conduct of Research Using Recombinant DNA, Douglas M. Costle, dated September 15, 1978. Box #4; F: FKN-112.

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On May 14, 1979 the EPA announced proposed policy on regulation of Òbiorational pesticides.Ó

Although recombinant DNA was not

specifically mentioned, it was clear that any microorganisms would be covered, that the private sector would be included, and that biological pesticides would be recognized as Òinherently different from conventional pesticidesÓ currently registered with EPA.2 5 7 Given the acknowledged interest in rDNA by the agricultural administration and the recognition by Fredrickson that the NIH would need the assistance of USDA, and given the status of USDA as a regulatory agency, CalifanoÕs failure in December 1978 to suggest the value of any input from the Department of Agriculture for regulating privately conducted rDNA research seems curious.

In fact a few months

later Califano indicated that he had received a suggestion (from an unnamed source) that USDA might have the authority to regulate privately conducted research in the agricultural area.

Thus Califano

approached the Secretary of Agriculture, Robert Bergland, for his support.2 5 8 BerglandÕs reply to Califano first reiterated the USDAÕs support of the oversight of recombinant DNA research by modification of the NIH Guidelines.

Bergland reviewed some statutes which he believed may

have been relevant to the regulation of rDNA products but he also indicated that Òthe authority of the USDA does not directly extend to the private sector for regulation of recombinant DNA r e s e a r c h.Ó2 5 9 What is 257

(44 FR 28093), emphasis added. Environmental Protection Agency. (1979). ÒRegulation of "Biorational" Pesticides; Policy Statement and Notice of Availability of Background Document.Ó Federal Register v. 44: 28093-28095. May 14. 258 Letter from Joseph Califano to Agriculture Secretary, Robert Bergland, dated February 26, 1979. Tolin archive; Box #4, Folder: FKN-114. 259 Letter from USDA Secretary, Robert Bergland, to HEW Secretary, Joseph

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more illustrative of USDAÕs reluctance to get involved in actual regulation of the industry and the research it promoted, and of its internal disagreement on the subject, is an unsigned draft response to Califano, prepared for BerglandÕs signature.

The rough draft had

indicated more strongly that USDA had neither the authority nor any plans to extend its authority to regulate private industry research, unless someone planned to transport materials across state lines or to import materials into the country.2 6 0

Clearly, the suggestion received by

Califano to include USDA in regulation of private industry and the draft letter for Bergland expressing the desire to exclude USDA from private sector involvement must have come from at least two different representatives to the A-RAC. According to David MacKenzie, a former colleague of FulkersonÕs at the CSRS, ÒThe university [agricultural] community, which John Fulkerson was leading in the early 1980Õs, hoped that the National Institutes of Health would extend the Guidelines to cover field testing Califano, dated June 27, 1979; emphasis added. Tolin Archive, Box #4, Folder: FKN115. 260 Undated draft letter prepared for the signature of Agriculture Secretary, Robert Bergland, to H.E.W. Secretary, Joseph Califano, which referred to CalifanoÕs letter dated February 26, 1979. Tolin archive; Box #4, Folder: FKN-114. Note: Rarely do high ranking government officials draft their own letters. Typically, an assistant drafts the letter, which may be revised by a supervisor before being presented to the official for more revisions and/or signature. Thus, it is conceivable that the early draft may have indicated the impression that a staffer had of the departmentÕs position. The original draft sentence, ÒAt the current time, we do not plan to extend our authority to this level,Ó might have been taken as a refusal to cooperate with the Secretary of HEW. Such an action would have been a direct challenge to President FordÕs mandate that all agencies cooperate with HEW on rDNA oversight. The signed copy substituted a less rigid statement, ÒThe authority of the USDA does not directly extend to the private sector for regulation of recombinant DNA research.Ó Per Sue Tolin, these letters were drafted by the A-RAC after discussion at a meeting with representatives from various divisions present. Personal communication with Sue A. Tolin, Ph.D. Professor of Plant Pathology, Physiology, and Weed Science, Former USDA representative to the NIH-RAC and OECD. Virginia Tech (various dates in 1998,

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outside contained laboratories.Ó2 6 1

98

Thus the Agriculture SecretaryÕs

letter harmonized well with the goals of John FulkersonÕs research group at the CSRS.

Fulkerson had always adhered to the belief that it

would be counter productive to have a different set of guidelines in each agency.2 6 2

Although the Land Grant System was more than happy

to provide consultation to the RAC, the agricultural r e s e a r c h leadership clearly believed that the NIH Guidelines could be modified to provide adequate oversight for the conduct of any and all rDNA activities and did not want to see rDNA regulated by statute. On the other hand, USDA was also a regulatory agency. It could be that this dual role played a part in USDAÕs overall disinclination to get too involved in regulating a technology that it was also promoting, lest itÕs actions be perceived as self-serving.

Although the Animal and Plant

Health Inspection Service (APHIS), in the regulatory division of the department, had statutes which USDA Secretary Bergland thought might have been relevant to products of biotechnology research, he responded to a November, 1977 query by U.S. Senator Adlai Stevenson (D-IL) that USDA could Ònot specifically point to any statute administered by APHIS which would be definitely applicable to [rDNA] r e s e a r c h.Ó2 6 3 For now, APHIS was kept in the background because CSRS and Fulkerson were in

1999). 261 Interview with David MacKenzie, Ph.D. Executive Director, NE Regional Assn of State Agr. Experiment Stations, formerly with CSRS, USDA. Washington, DC (December 9, 1997). MacKenzie is now Executive Director of the Northeast Regional Association of State Agricultural Experiment Stations. 262 Transcribed tape recording from a JCRC meeting of December 18, 1979. Tolin Archive; Box #1, Folder ARRC 1978-1982. 263 Letter, dated December 23, 1977, from USDA Secretary Robert Bergland to Senator Adlai Stevenson, Chairman, Subcommittee on Science, Technology, and Space. Tolin Archive, Box #4, Folder: FKN-114. Emphasis added.

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However, APHIS would later play a major role in the

development of U.S. biotechnology policy.

Summary During the gestation period of the Release Era, the USDA had agreed to the original RAC Guidelines so that research could continue.

However,

it was clear that changes would have to be made to allow the agricultural community to realize any benefits from the new technology. Researchers, primarily from Land Grant universities, began to challenge the prohibition on release into the environment several years before agricultural products came to the testing stage of development. Although agriculture had a very different set of risk/benefit issues from those of medicine, USDA preferred to use the NIH Guidelines rather than face the prospect of having to regulate the diversity of agricultural research possibilities separately.

APHIS regulations only

covered plant pests, not research or products.

While USDA continued to

rely on NIH oversight (because there was no alternative at the time), staff in two other agencies, FDA and EPA, were beginning to think ahead to the regulation of the private sector. In the next chapter, I take a closer look at how the RAC, inadequately staffed to handle agricultural questions, attempted to deal with an expanding responsibility.

CHAPTER FIVE: REGULATORY SCHIZOPHRENIA Introduction The NIH was the lead Federal agency for genetic engineering as long as it was in the research phase.

Research had progressed during the

1970s because the RAC Guidelines had offered some measure of assurance to the public that recombinant organisms would be strictly contained, either physically or biologically.

During the quiescent period

at the end of the Containment Era, the RAC was, Òquite frankly, running out of things to do if some new issues hadnÕt come up,Ó recalled Sue A. Tolin, who had been present at essentially all RAC meetings since mid1978 as a liaison representative for the USDA.2 6 4

However, changes in

RAC duties were imminent. The quasi-quiescent period of the Containment Era, which spanned the Carter years (1977-1981), was quiescent only so far as the general public was concerned.

At the same time, pressure mounted to conduct

risk assessment experiments aimed at eventual release of rDNA organisms for uses in agriculture..

The RAC had survived the first

lawsuits against the NIH that were related to decisions the committee had made. Now,

It had expanded the membership to include non-scientists.

the RAC had begun to receive pressure from the agricultural

community to allow it to conduct research where agricultural organisms grow--outside.

264

Personal communication with Sue A. Tolin, Ph.D. Professor of Plant Pathology, Physiology, and Weed Science, Former USDA representative to the NIH-RAC and OECD. Virginia Tech (various dates in 1998, 1999).

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The context in which the RAC was operating was also changing. Although there were some who still rejected the validity of the Ascot and Falmouth reports (see Chapter Three),2 6 5 the studies had given Congress an escape clause.

Lawmakers now had the basis upon which

to turn from opposing and regulating to supporting and nurturing the high-technology industry because of its potential for enhancing U.S. competitiveness in the international marketplace.

More significantly,

the leadership of both the Executive Branch and the U.S. Senate changed political parties with the victory of Republicans (traditionally associated with promotion, not regulation, of industry) in the 1980 election.

By

1983, the number of bills restricting rDNA research introduced in the Congress had dropped significantly.2 6 6 Coinciding with the Congressional change of heart was the market approval of Eli LillyÕs ÒHumulinÓ in 1982.2 6 7

The technology had moved

from research to medical product development, and there were many more products in the pipeline.

However, agriculture was still waiting

for the opportunity to do outdoor research.

As more information

became known about safety and risk, changes continued to be made to the RAC Guidelines, allowing more and more exemptions for research, eventually even to the section on prohibition of release into the environment. 265

See especially Wright, Susan, (1994). Molecular Politics: Developing American and British Policy for Genetic Engineering, 1972-1982. Chicago, University of Chicago Press. and Wright, Susan, (1986). ÒMolecular Biology or Molecular Politics? The Production of Scientific Consensus on the Hazards of Recombinant DNA Technology.Ó Social Studies of Science. v. 16 pp. 593-620. See p.616. 266 Uncited author, (1983). ÒGene Splicing Sheds Its Mad-Scientist Image.Ó N e w s w e e k. . May 16, p. 36. See p.36. 267 LillyÕs ÒHumulin,Ó a rDNA human insulin derived from bacteria, became the first rDNA product approved for marketing. Altman, L.K., (1982). Ò US Unit backs human insulin for the market.Ó New York Times. New York. October 30, p. A1.

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The purpose of this chapter is to examine some of the pressures that led to the discontinuation of the RAC as the primary bearer of the responsibility for federal oversight of all rDNA activities in the U.S.

The

RAC had been chartered to protect public health and the environment from hazards of federally funded, primarily medical, rDNA research.

It

was not designed to oversee private sector research, large scale production facilities, nor intentional environmental releases of living rDNA organisms.

Yet pressures to resolve these upcoming policy

dilemmas were unrelenting.

The uncertainty culminated in a scientific

threshold in the Release Era when the RAC received the first request for an exception to the prohibition against deliberate release of rDNA into the environment.

Regulatory Schizophrenia NIH was accustomed to keeping one particular host safe from potential pathogens--the human host.

Soon there would be all kinds of

hosts to consider: livestock and beneficial microorganisms, tomatoes and corn, perhaps even unknown, unintended hosts if rDNA were scattered willy nilly into the environment.

Although there was interest, from the

academic community in particular, in NIHÕs continuing to play a role in the oversight of environmental release issue, the NIH was justifiably hesitant about assuming responsibility for providing oversight of nonmedical applications of biotechnology.

In addition, research in the

private sector had advanced to the point where the RAC was receiving requests for exceptions to the 10-liter limit rule in the Guidelines.2 6 8

268

Experiments using more than 10 liters of culture were prohibited by the original RAC Guidelines at section III-A. (41 FR 27902).

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Industry was ready to scale up to production levels of rDNA organisms from which products could be harvested. On the one hand, there was the question of whether RAC was overstepping its bounds by advising on these additional matters. other hand, agency pride was at stake.

On the

According to Elizabeth Milewski,

formerly on the staff at ORDA, there was within the NIH a Òcertain level of schizophreniaÓ over the notion of regulating the release of rDNA into the environment.2 6 9

She recalled,

Ò(NIH) didn't want to be a lightening rod [for]... contentious issues.... At the same time they didn't necessarily trust the other agencies to do a really good job either, because they felt you needed really qualified technical people making these decisions. 2 7 0 Milewski further recollected, ÒI think NIH was not particularly eager to get into that area [environmental release], especially when we started getting applications for environmental testing and they ran into Jeremy Rifkin's lawsuits which essentially said they had to do Environmental Impact Statements [on everything]. NIH is primarily a funding institution, promoting research. ... They could by contract law require certain things of the grantees of their contracts. But once it went beyond that, they did not have the legal authority and didn't particularly want it.2 7 1

269

Milewski was Assistant to the Director, Office of Recombinant DNA Activities (ORDA) from 1979 until 1986, when she moved to the Environmental Protection Agency. Interview with Elizabeth Milewski, Ph.D. formerly on staff at NIH-ORDA, presently Special Assistant for Biotechnology, EPA. Washington, DC (December 5, 1997). 270 Ibid. 271 Ibid. The Rifkin lawsuit to which Milewski referred was FET v. Heckler, filed in 1983, which used NEPA to stop the release of genetically modified Ice-Minus bacteria into an agricultural test field. This case will be discussed in Chapter Seven.

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What began for the RAC as oversight of closely contained basic medical research was potentially blossoming into quasi-regulation of technology development in a wide variety of organisms, in both the public and private sector.

Furthermore, their decisions might be used

as supporting testimony in litigation.

Although it was becoming clear

that NIH was beginning to get in over its head, NIH leaders were still not sure they wanted to give up the gatekeeping position they had in what they believed to be a very important responsibility to the public. When Ronald Reagan was elected president in 1980, it became obvious that the new administration would not tolerate any additional laws or regulations that would hinder technology development, especially in the private sector.

(see Chapter Nine.)

George A. (Jay)

Keyworth, ReaganÕs science advisor and director of the Office of Science and Technology Policy (OSTP), aptly pointed out that ÒScience policy is not made in a vacuum.

It is an exercise in priority setting and decision

making that must be carried out in the context of other national policies....Ó2 7 2 It is reasonable to assume that, as an institution financially wellendowed by the Congress during a time of budget cuts promised by the incoming Reagan Administration, the leaders of NIH did not want Congressional support of their mission to be eroded by developing enemies who were opposed to their taking regulatory actions for which they had no legal authority.

Allowing exceptions to prohibitions of the

new Guidelines so soon after they had been promulgated, even if 272

Keyworth testimony, in U.S. Congress, House of Representatives, Committee on Science and Technology, (1982). U.S. Science and Technology Under Budget Stress. U.S. Government Printing Office. Washington, DC. December 10, 1981 and February 2,3,4, 1982. Hearings. 97/118. See p.6.

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scientifically reasonable, might have been politically unwise. Nevertheless, although NIH had no clear Congressional authority to regulate rDNA, especially regarding release into the environment, it could not easily pass the responsibility to other agencies either.

There

was neither the specific authority to regulate rDNA anywhere else in the Executive Branch, nor the desire of the Administration to allow the creation of it.

The RAC in the Wringer During the Carter years, the RAC had been expanded to include more public participation and the views of experts other than scientists.

Even

as the RAC was becoming more Òparticipatively democratic,Ó tremendous pressure was being exerted upon it, especially by many of the same scientists who had signed the original moratorium letter, to relax the Guidelines.

Some of the new challenges faced by the RAC are

detailed in this section. Voluntary

Compliance

The idea of voluntary compliance by non-federally funded institutions with the NIH Guidelines had first been broached in January of 1980.2 7 3

A year later, with a new Republican Administration in place,

it was suggested that the Guidelines be converted to a voluntary code of standard practice.2 7 4

The proposal, submitted by RAC members, Allan

Campbell and David Baltimore, would also have eliminated the requirement for RAC review for previously prohibited experiments,

273

(45 FR 6746). Minutes of the RAC meeting, April 23-24, 1981 documents 994, 1015/II, and 1017. 274

See pp.8-15.

See also RAC

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including release into the environment,2 7 5 and would have reduced containment levels for many experiments.2 7 6 While dismissal of the mandatory Guidelines would have been in harmony with the new Republican White House agenda and the desires of many molecular biologists, the relaxation of oversight was not viewed the same way by the predominantly Democratic Congress nor by activist groups such as the Committee for Responsible Genetics.2 7 7

By November

of 1981, RAC chairman, (former Congressman, D-AR), Ray Thornton had received a hand-delivered letter from his former colleagues in the House of Representatives.

Democratic leaders of the House Committee

on Science and Technology, Donald Fuqua (FL), Doug Walgren (PA), and Albert Gore, Jr. (TN), voiced concern over the Baltimore-Campbell proposal to make the Guidelines voluntary.2 7 8

In the letter the three

congressmen worried, ÒIf the Guidelines become only a voluntary code of standard practice, private firms will be more likely not to comply.Ó The letter also endorsed the right of the public to expect accountability for public funding of science and reiterated the need for assurance that rDNA organisms would not be released into the environment. 275

Minutes of the RAC meeting, September 11, 1981, in U.S. Department of Health and Human Services, (1982). Documents Relating to "NIH Guidelines for Research Involving Recombinant DNA Molecules" November 1980-August 1982, Office of Recombinant DNA Activities, NIH Publication No. 83-2604. See p.202. 276 National Institutes of Health. (1981). ÒRecombinant DNA Research; Proposed Actions Under Guidelines.Ó Federal Register v. 46: 17994-17997. March 20, Part IV.. See p.17995. 277 See any issues of GeneWATCH, news bulletins of the CRG during this period. 278 Letter dated November 20, 1981 is reproduced in U.S. Department of Health and Human Services, (1982). Documents Relating to "NIH Guidelines for Research Involving Recombinant DNA Molecules" November 1980-August 1982, Office of Recombinant DNA Activities, NIH Publication No. 83-2604. See p.618-620. Fuqua was the chairman of the full House Committee on Science and Technology, Gore was the chairman of the Subcommittee on Investigations and Oversight, and Walgren was the chairman of the Subcommittee on Science, Research, and Technology for the 98th Congress.

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In reference to the Congressional letter, Dr. Winston Brill, from the University of Wisconsin, wrote to William Gartland, the Director of NIH ORDA, that there was Òno way to be absolutely sure that no danger can exist in any technology.Ó2 7 9

Yet, in the same letter, Brill opined that

worry about rDNA was ÒunnecessaryÓ.

Brill was also Director of

Research at the private biotechnology firm, Cetus Madison as well as a member of the RAC.

His letter also expressed a greater concern that

restricting U.S. agricultural researchers to Òarbitrary rulesÓ that prohibited release of rDNA into the environment would give a competitive advantage to countries with oversight that was less restrictive. In December of 1981, the Baltimore-Campbell proposal, as well as an alternate proposal submitted by RAC member Susan Gottesman, were put forth for public comment.2 8 0

The main differences between the two

proposals and the then current RAC Guidelines were related to voluntary compliance, prohibitions, and containment levels.

The

Baltimore-Campbell proposal would have made the Guidelines voluntary for all investigators, all prohibitions would have been eliminated, and no prior approval, even of the local Institutional Biosafety Committee (IBC), would have been required, because any study could be performed on a laboratory bench using standard microbiological safety precautions. 279

The Gottesman proposal retained

Letter dated January 5, 1981 from Brill to Gartland is reproduced in U.S. Department of Health and Human Services, (1982). Documents Relating to "NIH Guidelines for Research Involving Recombinant DNA Molecules" November 1980August 1982, Office of Recombinant DNA Activities, NIH Publication No. 83-2604. See p.560-561, Emphasis original. 280 The Baltimore-Campbell proposal was published in (46 FR 59368) on December 4, 1981. The Gottesman proposal was published in (46 FR 59734) on December 7, 1981.

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the mandatory nature of the Guidelines, replaced ÒprohibitionsÓ with ÒRAC review and NIH approval before initiationÓ and greatly simplified recommendations for containment, but retained IBC approval r e q ui r emen t s.2 8 1 Letters of comment poured forth in the month of January, 1982. Overwhelming support for the Baltimore-Campbell proposal came from several signers of the Berg letter.

For example, letters received from

Paul Berg, Norton Zinder, Stanley Cohen, and Daniel Nathans all supported the Baltimore-Campbell proposal to make the Guidelines completely voluntary.2 8 2

Even Maxine Singer and Dieter Soll, authors of

the very first letter of concern regarding rDNA, endorsed the measure, although Singer expressed some reservations.

When other proposals

were offered as alternatives to Baltimore-Campbell, Singer changed her allegiance to the Gottesman version.2 8 3 At one extreme were those who preferred to forget public oversight of rDNA altogether.

For example, Norton Zinder of Rockefeller

University said that he preferred Òthat the Guidelines be rescinded,Ó and 281

Memo from William Gartland, Director, NIH ORDA to Òinterested partiesÓ in U.S. Department of Health and Human Services, (1982). Documents Relating to "NIH Guidelines for Research Involving Recombinant DNA Molecules" November 1980August 1982, Office of Recombinant DNA Activities, NIH Publication No. 83-2604. See p.320-324. 282 Collection of comment letters in Ibid. U.S. Department of Health and Human Services, (1982). Documents Relating to "NIH Guidelines for Research Involving Recombinant DNA Molecules" November 1980-August 1982, Office of Recombinant DNA Activities, NIH Publication No. 83-2604. This collection of letters may or may not be representative of all letters received. Letters from the following persons appear on the pages indicated: Paul Berg (p.592), Norton Zinder (p.581), Stanley Cohen (p.625), and Daniel Nathans (p.635), Maxine Singer (p.587), Dieter Soll (p.647). 283 Collection of comment letters in Ibid. U.S. Department of Health and Human Services, (1982). Documents Relating to "NIH Guidelines for Research Involving Recombinant DNA Molecules" November 1980-August 1982, Office of Recombinant DNA Activities, NIH Publication No. 83-2604.. SingerÕs change of view (pp.606 and 715).

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claimed that if they were retained it would be for Òpolitical and social reasons.Ó2 8 4

Apparently he believed that these were not legitimate

objectives for science policies.

Zinder had proposed that the Guidelines

and the RAC be altogether eliminated, but his request for such a motion was ignored. Predictably, at the other extreme, several members of the governing boards of the Coalition/Committee for Responsible Genetics (CRG) were opposed to any proposal that would weaken the restrictions on rDNA.2 8 5 Philip Bereano, Ruth Hubbard, Claire Nader (sister of activist Ralph Nader), Jonathan King, Barbara Rosenberg, Susan Wright, and George Wald all expressed a desire to s t r e n g t h e n, not weaken, public control of rDNA.2 8 6

More than one of these respondents reproached another Nobel

Laureate, RAC member David Baltimore, for conflict of interest, accusing him of promoting the deregulation of an industry in which he had a considerable economic interest.2 8 7

Conflict of interest would be a

recurring theme in the rDNA debate and a valuable weapon for critics of rDNA; especially those who believed that scientists were willingly 284

Minutes of RAC meeting, September 10-11, 1981, p.6, in Ibid. U.S. Department of Health and Human Services, (1982). Documents Relating to "NIH Guidelines for Research Involving Recombinant DNA Molecules" November 1980-August 1982, Office of Recombinant DNA Activities, NIH Publication No. 83-2604. See p.197. 285 Membership, as well as the name of the CRG changed during this time period. All of the names mentioned here were at some point listed as members of governing boards of the CRG. 286 Collection of comment letters in U.S. Department of Health and Human Services, (1982). Documents Relating to "NIH Guidelines for Research Involving Recombinant DNA Molecules" November 1980-August 1982, Office of Recombinant DNA Activities, NIH Publication No. 83-2604. Philip Bereano (p.594), Ruth Hubbard (p.717), Claire Nader (p.601), Jonathan King (p.719), Barbara Rosenberg (p.658), Susan Wright (p.603), and George Wald (p.701). For more information on CRG see Council for Responsible Genetics, (August 18, 1997). ÒProfiles of the Board of Directors and Key StaffÓ. CRG. Accessed December 30, 1998. 287 Ibid. (HHS, 1982) Hubbard (p.717) Jonathan King (p.719 See p. 5 of his letter) and George Wald (p.701) each brought up the conflict of interest charges.

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placing unprecedented power in the hands of global corporations, thus supporting the longing of corporation owners Òto dictate our lives.Ó2 8 8 Although Congressmen Fuqua, Walgren, and Gore expressed concerns that the private sector might not comply with the Guidelines if they were completely voluntary, the industry strongly supported NIH involvement as a safety measure.

Letters from Monsanto, Lilly

Research Laboratories, Genentech, the Industrial Biotechnology Association (IBA), and the American Society for Microbiology (ASM) all indicated a desire for NIH to maintain some kind of standards, although Monsanto, Lilly, and ASM did not specify a preference for a particular alternative.2 8 9

Because the FDA had required that all new product

submissions must show documentation that the Guidelines had been followed, elimination of the Guidelines would have left an ambiguous void for private industry.2 9 0

The FDA clearly sided with voluntary

compliance, because their representatives felt that FDA review of the products under their jurisdiction was sufficiently rigorous to assess those products regardless of the mode of manufacture.2 9 1 The private sector certainly must have recognized that, in the simultaneous presence of uncertainty about rDNA and the absence of

288

Rifkin, Jeremy, (1983). A l g e n y. New York, Viking Press. See p.2. Collection of comment letters in U.S. Department of Health and Human Services, (1982). Documents Relating to "NIH Guidelines for Research Involving Recombinant DNA Molecules" November 1980-August 1982, Office of Recombinant DNA Activities, NIH Publication No. 83-2604.. Monsanto (p.713), Lilly Research Laboratories (p.727), Genentech(p.750), Industrial Biotechnology Association (p.753), and American Society for Microbiology (p.659). 290 (43 FR 60134). 291 Meeting minutes of the Large-Scale Review Working Group, September 9, 1981 p.183; 187.in U.S. Department of Health and Human Services, (1982). D o c u m e n t s Relating to "NIH Guidelines for Research Involving Recombinant DNA Molecules" November 1980-August 1982, Office of Recombinant DNA Activities, NIH Publication No. 83-2604. 289

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official regulations, the RAC stamp of approval was the only thing they had to afford them a measure of legal protection in the event of an unforeseen catastrophe.

The rationale behind judge-made ÒtortÓ or civil

law is that an innocent, injured party should not be made to bear losses imposed by a second party who is in pursuit of his/her own interests. Geoffrey Karny, formerly of the Congressional Office of Technology Assessment, emphasized that the Guidelines would be viewed by judges in tort cases as quasi-regulations, whether they were mandatory or voluntary, and that Ò[f]ailure to follow the Guidelines (would) virtually guarantee a finding of negligenceÓ.2 9 2 amounted to an insurance policy.

Therefore, a RAC review

The only caveat in reviewing private

sector proposals was the need to protect confidential business information, which in turn necessitated the RACÕs meeting in executive session to review some parts of proposals.

Having to close doors to the

public for meetings which were otherwise open to the public presented the agency with a dilemma. The ÒLarge ScaleÓ Issue

At the same time, the RAC was being urged to increase the limit on the quantity of rDNA organisms that could be produced in one experiment.

Research in the private sector had advanced to the point

where industry wanted exceptions to the 10-liter limit rule in the Guidelines so they could scale up to production levels of rDNA organisms from which they would harvest products.

292

For example, Eli

Karny, Geoffrey M., (1981). ÒRegulation of Genetic Engineering in the Food and Agriculture Industries.Ó Recombinant DNA Technical Bulletin. v. 4 (4) (December) pp. 152-156. See p.155.

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Lilly was prepared to scale up its rDNA human insulin proteins production as early as 1979.2 9 3 The Large-Scale Review Working Group of the RAC held its first meeting on April 22, 1981.2 9 4

One of the concerns expressed at that

first meeting was that industry was beginning to use many systems other than E. coli, yet all risk assessment data up to that point was on E. coli alone.2 9 5

Although early submissions of large-scale protocols dealt

with human health products, one advantage to agriculture of the largescale issue was that it forced the RAC to begin to consider many more organisms as potential hosts and vectors for rDNA research. Ironically, large-scale industrial production of rDNA organisms was probably no more ÒdangerousÓ than production of small quantities because there was economic pressure to be exceedingly careful not to contaminate cultures or to allow living organisms to survive outside of the fermentation tanks.

Frank Young, a member of the RAC in 1979 and

1980, related an instructive experience he had while deliberating on large scale issues and the release from fermentation tanks into the environment. ÒWe soon realized that most industrial firms were extraordinarily careful [not to let organisms escape], because they didnÕt want their strains stolen.Ó2 9 6

293

(45 FR 28904). Minutes of Large-Scale Review Working Group of the RAC, April 22, 1981, in U.S. Department of Health and Human Services, (1982). Documents Relating to "NIH Guidelines for Research Involving Recombinant DNA Molecules" November 1980-August 1982, Office of Recombinant DNA Activities, NIH Publication No. 832604. See p.78 295 Ibid. p. 82. 296 Interview with Frank E. Young, P. D. M.D. former Commissioner, U.S. Food and Drug Administration. Washington, DC (December 18, 1997).. After serving on the RAC, Dr. Young was Commissioner of the FDA under Reagan from 1984 until 1989. 294

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Thus, the need to protect confidential business information provided an incentive to exercise care in experimentation that was as strong as the incentive to guard proprietary information. The RAC Tackles Release at Last

The first request to field test whole plants containing rDNA arrived in February of 1980 from a Stanford University group of investigators headed by Ronald W. Davis, one of the signers of the Berg letter.2 9 7 The plan was a bold one.

The Stanford group wanted to develop a means of

transferring extra corn genes into corn plants, using rDNA, without previous indoor laboratory studies.

The transformation of the corn,

using pollen, was to take place directly in an outdoor field.2 9 8 The protocol appeared for public comment as a proposed major action in the Federal Register of April 30, 1980.2 9 9

Amazingly, not a single public

comment was received during the publicized 30 day comment period.3 0 0 The corn project was approved at the June 5-6, 1980 RAC meeting by a vote of eleven in favor, none opposed, and five abstentions, this despite not having received complete information on exactly how the corn would be transformed.3 0 1

Despite RAC approval, however, Director

Fredrickson deferred action pending more information on the proposed

297

Set of correspondences from Ronald Davis, Stanford University Medical School to Jane Setlow, RAC chairperson, dated February 9 (two letters), and March 18 (one letter). Tolin Archive; Box #4, Folder FKN-116. 298 Telephone interview with Ronald W. Davis, Ph.D. Professor of Biochemistry, Stanford University (September 23, 1999). 299 (45 FR 28904). 300 (46 FR 40331). 301 Minutes of the RAC meeting, June 5-6, 1980, p.32-33, in U.S. Department of Health and Human Services, (1981). Documents Relating to "NIH Guidelines for Research Involving Recombinant DNA Molecules" January 1980 - December 1980, Office of Recombinant DNA Activities, NIH Publication No. 81-2386., see pp.101-139.

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containment of the corn, which was not provided until the following y e a r .3 0 2 The case was also forwarded to the USDAÕs A-RAC for review. At their May 20, 1981 meeting, the corn proposal was discussed, but the A-RAC Òdid not necessarily concur in Dr. DavisÕ assessment that his research proposal was completely without risk to the corn crop.Ó3 0 3 Furthermore, Dr. Davis had still not supplied workplans nor important details such as location of the test field.3 0 4

Hence, the A-RAC decided

that it Òcould not adequately consider the proposal until the information was furnished by Dr. Davis.Ó3 0 5 It was not until after FredricksonÕs resignation from the Directorship of NIH that the Davis proposal was finally approved.3 0 6

By private

memo on June 22, 1981 Fredrickson had delegated all of his directorship duties, including responsibilities for the RAC and the Chairmanship of the Federal Interagency Advisory Committee on Recombinant DNA Research (IAC), to Richard Krause, then Director of

302

(45 FR 50524). Also, Memo from William Gartland, Director of ORDA, to Richard Krause, Director, NIAID, dated July 30, 1981. Tolin Archive; Box #4, Folder FKN116. 303 Minutes of the A-RAC meeting of May 20, 1981, p.1. Tolin Archive, Box #4, Folder: FKN-119. 304 Ibid. 305 Ibid. Interestingly, a slightly different view was implied in a letter written almost a year earlier by Sue A. Tolin, a plant pathologist/virologist, to William Gartland, ORDA, dated August 7, 1980. Tolin wrote, ÒIn general, we [A-RAC] see no hazard to man or the environment by growing in a field, corn that contains a segment of corn DNA introduced as a recombinant molecule, provided it is done in compliance with the NIH Guidelines.Ó Tolin Archive, Box #10, Folder: EA-Corn, 1980-1981. 306 Donald Fredrickson resigned as NIH Director on June 30, 1981. For a period of 10 months, NIH had acting directors (Krause and Thomas Malone) before James Wyngaarden was appointed on April 30, 1982. National Institutes of Health, (1996). ÒNIH Almanac: Biographical Sketches of the Directors of the National Institutes of HealthÓ. NIH. Accessed December 29, 1997..

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the National Institute of Allergy and Infectious Diseases (NIH-NIAID).3 0 7 Final approval for the Davis corn proposal was announced on August 7, 1 9 8 1 .3 0 8 It was not an easy road to that approval.

Submissions of the protocol

were considered incomplete and there were delays in providing the extra information requested by the RAC and the A-RAC.

Davis was

convinced that any hazards associated with the project were nothing more than hypothetical and that there should be Òno controls over field testing of a corn plant.Ó3 0 9

He also suspected that the RACÕs vague

requests for more information indicated that they really did not know what it was they needed to know in order to make a decision on the protocol.3 1 0 By enhancing the genes for two amino acids which are normally produced only in small quantities in corn, a product could have been made that contained a full complement of the amino acids which are essential to the human diet.3 1 1 307

However, the project never went

U.S. Department of Health and Human Services, (1982). Documents Relating to "NIH Guidelines for Research Involving Recombinant DNA Molecules" November 1980-August 1982, Office of Recombinant DNA Activities, NIH Publication No. 832604. See p.597. 308 (46 FR 40331). August 7, 1981. Memo from William Gartland, Director of ORDA, to Richard Krause, Director, NIAID, dated July 30, 1981. Tolin Archive; Box #4, Folder FKN-116. This memo reviews the regulatory path negotiated by the corn proposal and shows KrauseÕs signature of approval dated July 30. 309 Letter from Ronald W. Davis to William Gartland, NIH-ORDA, dated December 19, 1980, referring to GartlandÕs letter of September 19. Tolin Archive, Box #10, Folder: EA-Corn, 1980-1981. 310 Telephone interview with Ronald W. Davis, Ph.D. Professor of Biochemistry, Stanford University (September 23, 1999). 311 Krimsky, Sheldon, (1987). ÒGene Splicing Enters the Environment: The SocioHistorical Context of the Debate Over Deliberate ReleaseÓ in Application of Biotechnology: Environmental and Policy Issues. J. R. Fowle, III, Ed. Boulder, CO. Westview Press for the American Association for the Advancement of Science. pp. 27-53. See p.35. This pioneering effort (adding to corn plants extra copies of corn genes) brings to mind the scenario described in Chapter Two in which McClintock observed what was later described as the natural generation of extra copies of

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forward to the field, despite its perceived great benefit to risk ratio.

It

is possible that the costs in time and money of negotiating federal red tape were too much for the investigator to bear.

It is also possible that

the protocol was only intended as a political tool; a test case to force the hand of the NIH on the release issue, so that subsequent investigators could benefit.

Summary The RAC was in the ambiguous position of having been given responsibility without authority.

Like it or not, the ÒNIH was acting as

de facto regulator for rDNA activities without enforcement powers or congressionally derived authority.Ó3 1 2

Once the Reagan Administration

was in the White House, supported by a Republican Senate, it was unlikely that there would be any new Congressional authority forthcoming to cover rDNA.

Yet, there had already been lawsuits filed

against the NIH in opposition to RAC decisions, which made a difficult job even more onerous.3 1 3

What began for the RAC as supervision of

closely contained basic biomedical research quickly blossomed into oversight of technology development in a wide variety of organisms, in both the public and private sector.

The RAC had

little experience with

certain genes in maize. 312 Krimsky, Sheldon, (1987). ÒGene Splicing Enters the Environment: The SocioHistorical Context of the Debate Over Deliberate ReleaseÓ in Application of Biotechnology: Environmental and Policy Issues. J. R. Fowle, III, Ed. Boulder, CO. Westview Press for the American Association for the Advancement of Science. pp. 27-53. See p.33. 313 In May of 1977, the first two lawsuits were brought against the NIH regarding rDNA; one by activist group Friends of the Earth to enjoin all recombinant DNA research, and another by Ferdinand Mack to block a risk assessment study. Fredrickson, Donald S., (1979). ÒA History of the Recombinant DNA Guidelines in the United States.Ó Recombinant DNA Technical Bulletin. v. 2, no.2 (July) pp. 8790. See p.89.

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industrial-scale protocols or with the vast diversity of agricultural organisms. Even with its several working groups, which often included ad hoc experts, the RAC members were clearly in over their heads, and being squeezed into a role for which the RAC had no official authority. The RAC Guidelines had been taken as a s u b s t i t u t e for regulations, although its only official role was to advise on containment for protocols they judged to present acceptable levels of risk. A great diversity of challenges threw the membership into a temporary period of uncertainty as the RAC tried to decide how best to approach the formidable tasks.

Although a major advantage of the RAC

was its public participation aspect, little interest had been shown.

Up to

this point, so far as the general public was concerned, agricultural biotechnology and the potential for planned releases of rDNA organisms was a futuristic theory, not an immediate concern. change.

That would soon

CHAPTER SIX: THRESHOLD OF THE RELEASE ERA: FROM THEORY TO REALITY Introduction In the early 1980s, the promise of products fabricated through new combinations of DNA that transcended species barriers went from theory to reality.

Medical products had reached the testing and

marketing stages and agricultural research would very soon be ready to leave the laboratory. rekindled.

Public interest in rDNA could not help but be

Biotechnology was no longer lurking in the realm of science

fiction. It was r e a l.

Not only real; it was scratching at the laboratory

door to be let out. In this chapter, I examine selected milestones from the early 1980s that demonstrate the crossing of a threshold into the public arena.

This

led to the repolarization of rDNA debate participants during the Release Era of the controversy.

Diamond v. Chakrabarty Spearheads Genetic Gold Rush In a landmark Supreme Court case decided on June 16, 1980 Ananda Chakrabarty, a microbiologist with the General Electric Company, was granted the right to patent Òa bacterium from the genus Pseudomonas containing therein at least two stable energy-generating plasmids, each of said plasmids providing a separate hydrocarbon degradative pathway.Ó3 1 4 314

President CarterÕs Commissioner of the U.S. Patent and

Diamond v. Chakrabarty, U.S. Supreme Court Opinion No. 79-136, decided June 16, 1980. Chief Justice Burger delivered the opinion of the Court. A dissenting opinion was written by Justice Brennan, who argued, among other things, that Congress specifically excluded bacteria from patent laws.

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Trademark Office, Sydney A. Diamond, had refused to grant a patent to Chakrabarty because the oil-digesting bacterium that Chakrabarty had constructed was a living thing.

The Supreme Court vote was a close one:

five votes to four to allow the patenting of life forms if there were a human intervention component to them.3 1 5 The question before the Supreme Court was a narrow statutory interpretation of Title 35 USC ¤101, which provides: ÒWhoever invents or discovers any n e w and useful ... manufacture, or composition of matter ... may obtain a patent therefor ... (emphasis added).Ó3 1 6 The majority considered the Chakrabarty bacterium a ÒnewÓ construction of matter because he had manipulated it to contain several plasmids which had never occurred simultaneously in the same organism before.

They

also deemed the bacterium ÒusefulÓ because it could be used to clean up oil spills, which had become a popular concern of environmentalists during the 1970s.

The Supreme Court affirmed the U.S. Court of

Customs and Patent AppealsÕ decision that ChakrabartyÕs organism was both new and useful and the fact that it also happened to be alive was deemed irrelevant. Although the creation of the oil-eating bacteria did not involve rDNA, over 100 patent applications based on rDNA technology had been delayed while the U.S. Patent and Trademark Office argued that it was not the intent of existing patent law to allow the patenting of living

315

Diamone v. Chakrabarty. See also Wade, Nicholas, (1980). ÒCourt Says Lab-Made Life Can Be Patented.Ó S c i e n c e. v. 208 (June 27) p. 1445. It is interesting to note that there is a correlation between Justices who voted in ChakrabartyÕs favor and the political party of the presidents who appointed them (five Republican appointees for; both Democrats and two Republican appointees against the patent). See Appendix C in this dissertation. 316 A third requirement for a patent is that the invention be Ònon-obvious.Ó

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Thus, the commercialization of biotechnology was highly

influenced by the 1980 Supreme Court decision.3 1 8 From an economic standpoint, Chakrabarty opened the gates to exciting new opportunities for investors and increased the enthusiasm of the private sector for the use of rDNA technology.

The lack of

Congressional response to revise the patent statutes following the Supreme Court action also contributed to the genetic engineering Gold Rush as companies, large and small, sought a profitable enterprise in biotechnology.

For example, a few months after Chakrabarty, in

October, 1980 before a single product was forthcoming, Genentech Òstock soared from $35 to $89 a share within minutes of the opening offer, and the company raised $55 million in a few frantic hours of trading.

Not far behind was Cetus ... which set a Wall Street record in

1981 for the largest amount of money--$115 million-- raised in an initial public stock offering.Ó3 1 9 The Supreme Court decision was not only relevant to technology development and to venture capitalists, it was to become relevant in the battle over regulation of the release of rDNA organisms into the environment.

The EPAÕs claim of jurisdiction over release of any rDNA

microorganism into the environment under the Toxic Substances Control Act (TSCA) would be dependent upon redefining rDNA organisms as ÒnewÓ chemicals.

According to the decision written by Chief Justice

Burger in Chakrabarty, the respondentÕs organism (although non317

Wade, Nicholas, (1980). ÒCourt Says Lab-Made Life Can Be Patented.Ó S c i e n c e. v. 208 (June 27) p. 1445. 318 Plein, L. Christopher, (1990). ÒBiotechnology: Issue Development and EvolutionÓ in Biotechnology: Assessing Social Impacts and Policy Implications. D. J. Webber, Ed. Westport, CT. Greenwood Press. . See p.148. 319 Doyle, Jack, (1985). Altered Harvest: Agriculture, Genetics, and the Fate of the

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recombinant) was a genetic construction constituting Òa n e w bacterium with markedly different characteristics from any found in nature....Ó3 2 0 The language in the Supreme Court decision would be supportive of the EPAÕs claim of jurisdiction. The Animal and Plant Health Inspection Service (APHIS) of USDA, which would eventually become involved in regulation of biotechnology, would also look to Chakrabarty as a precedent.

Using the case as an

analogy, USDA attorney Terry L. Medley reasoned that rDNA could be regulated by a statute that was written before rDNA existed, provided the oversight was carried out within the intent of the statute for protecting American agriculture.3 2 1

APHIS would one day regulate

rDNA using a variety of statutes written in the first half of this century. This illustration represents an underappreciated example of how the Judicial Branch can be instrumental in federal policy making by providing an authoritative definition, or by defining the limits of a statute, which can later be used to correct the path of science policy.

A Letter From Three General Secretaries The Supreme Court decision also opened a painful new wound for those who believe that life is sacred.

In a letter dated June 20, 1980,

only four days after the Chakrabarty decision, the general secretaries of the national councils representing three of the countryÕs largest

World's Food Supply. New York, Viking Penguin, Inc. See p.25-26. 320 Diamond v. Chakrabarty, U.S. Supreme Court Opinion No. 79-136, June 16, 1980, p.S-8. Emphasis added. 321 MedleyÕs interpretation of C h a k r a b a r t y was that the Supreme Court specifically held that although the utility patent had not covered the patenting of living organisms, the microbe's development was consistent with the i n t e n t of the utility patent. Interview with Terry L. Medley, J.D. former Director of USDA-BBEP and Administrator of APHIS, USDA. Washington, DC (December 11, 1997).

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religious groups appealed directly to President Jimmy Carter to address the moral, ethical, and religious implications of engineering living organisms.3 2 2

The letter, which identifies the Supreme Court decision as

one Òthat could not have been imagined when patent laws were written,Ó cautioned that released, engineered life forms could not be recalled if they became noxious after they had become established in the environment.

But the spiritual leadersÕ main concern seemed to be

the threat to humanity posed by irresponsible individuals who might be tempted to Òplay GodÓ with rDNA organisms if they were given unsupervised control of the technology.3 2 3

The three secretariesÕ letter

claimed that Òno government agency or committee is currently exercising adequate oversight or control, nor addressing the fundamental ethical questions [of genetic engineering] in a major way.Ó3 2 4

They further demanded wide public consultation, stronger

government oversight, and a revision of patent laws to address rDNA organisms, all on both national and international levels. President Carter responded to their concerns by requesting an investigation of the matter by the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research 322

Letter dated June 20, 1980 and signed by Dr. Claire Randall, General Secretary, National Council of Churches, Rabbi Bernard Mandelbaum, General Secretary, Synagogue Council of America, and Bishop Thomas Kelly, General Secretary, United States Catholic Conference, is reproduced in Appendix B of Splicing Life. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, (1982). Splicing Life: A Report on the Social and Ethical Issues of Genetic Engineering with Human Beings. U.S. Government Printing Office. Washington DC. November. Report. 323 The spiritual leaders wrote, ÒThose who would play God will be tempted as never before.Ó Ibid. p. 96 324 President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, (1982). Splicing Life: A Report on the Social and Ethical Issues of Genetic Engineering with Human Beings. U.S. Government Printing Office. Washington DC. November. Report.

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(hereafter the PresidentÕs Commission).

123

The report of the PresidentÕs

Commission was released in 1982 under the title, Splicing Life: A Report on the Social and Ethical Issues of Genetic Engineering with Human Beings. It is noteworthy that religious leaders would join together in challenging the adequacy of government oversight of a new technology that posed a potential affront to their shared belief systems.

Religion,

as a major component of culture, plays a large role in the development of an individualÕs personal world view, which in turn influences the choices that one makes regarding the acceptance of new technologies. In the final chapter of this work, I will address the issue of world view and its impact on choices made during the rDNA controversy.

Splicing Life The report of the PresidentÕs Commission, entitled Splicing Life, was the product of a two year study.

Among the topics addressed by the

report were RACÕs role in the history of rDNA oversight, the appropriateness of human applications of rDNA such as gene therapy, and the concept of Òplaying God.Ó

The latter notion was dissected in

order to Òdifferentiate important claims about means and consequences from rhetorical claims.Ó3 2 5

However, although Splicing Life examined

possible origins of claims that genetic engineering represented an affront to God, it did not attempt to uncover any underlying motivations for using such claims rhetorically. The PresidentÕs Commission recommended broadening the RAC, creating a Human Gene Therapy Subcommittee, and creating an 325

Capron, Alexander Morgan, (1990). ÒThe Impact of the Report, Splicing Life. Ó

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oversight body in the Executive Office of the President.3 2 6 All of these recommendations would come to fruition.

The report was distributed in

November, 1982, at a hearing of the U.S. House of Representatives Committee on Science and Technology, Subcommittee on Investigations and Oversight, chaired by then Representative Al Gore, Jr. (D-TN).

Mr.

Gore was reported to have announced his intentions at that time Òto introduce legislation to create an independent genetic engineering commission.Ó3 2 7 Although the PresidentÕs Commission Report, Splicing Life, had little to do directly with environmental release of rDNA, the timing of the report was significant.

Oversight of rDNA projects was getting more

complicated and many RAC members clearly were out of their elements when considering many of the agricultural applications, even with input from USDA and ad hoc advisors who were frequently consulted.

The

PresidentÕs Commission Report suggested a potential escape hatch for the RAC.

By specializing in an avenue of rDNA oversight geared toward

human applications, the RAC would retain a raison dÕ•tre even if other responsibilities (such as oversight of environmental release or private sector protocols) were eventually relinquished.

Human Gene Therapy. v. 1 (Spring) pp. 69-71. See p.70. 326 President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, (1982). Splicing Life: A Report on the Social and Ethical Issues of Genetic Engineering with Human Beings. U.S. Government Printing Office. Washington DC. November. Report. 327 Mr. GoreÕs comment was reported by Robert Mitchell, RAC member, in the Minutes of RAC meeting, April 11, 1983, p.6; in U.S. Department of Health and Human Services, (1986). Documents Relating to "NIH Guidelines for Research Involving Recombinant DNA Molecules" September 1982 - September 1984, Office of Recombinant DNA Activities, NIH Publication No. 86-2863. See p. 91. During the first session of the 98th Congress (1983) Gore introduced H.R. 2788, A Bill to establish the PresidentÕs Commission on the Human Applications of Genetic Engineering.

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Requests to Release rDNA Organisms into the Environment Meanwhile, the RAC was being asked for exceptions to the most fundamental principle of the rDNA Guidelines--the prohibition against deliberate environmental release of organisms containing rDNA.

Recall

that the original Guidelines were promulgated in order to assure the safety of rDNA experiments.

This essentially meant containment

(physical or biological) because there was no information on which to make a judgment about the safety of released rDNA organisms. The first three requests for exceptions to the RAC Guidelines for release of rDNA into the environment were from university scientists at Stanford University, Cornell University, and the University of California at Berkeley (U.C.-Berkeley).

The 1980 Stanford proposal to enhance

corn with extra corn genes directly in the field was introduced in Chapter 5.

The test never went forward, but it broke the proverbial ice

by quietly becoming the first RAC-approved protocol for the release of a rDNA-containing organism into the outdoor environment.3 2 8 On September 22, 1982 a Federal Register notice announced that the RAC had received two more requests to release organisms containing rDNA into the environment.3 2 9

It was becoming obvious that rDNA

would soon no longer be an obscure, contained research issue with risk takers limited to a few laboratory workers.

These two requests were

discussed at the RAC meeting of October 25, 1982 as summarized here.

328

Minutes of the RAC meeting, June 5-6, 1980, p.32-33, in U.S. Department of Health and Human Services, (1981). Documents Relating to "NIH Guidelines for Research Involving Recombinant DNA Molecules" January 1980 - December 1980, Office of Recombinant DNA Activities, NIH Publication No. 81-2386. See pp.101139. 329 (47 FR 41924).

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Tomato and Tobacco Transformation

One request was from Dr. John Sanford of Cornell University for permission to field-test tomato and tobacco plants, which were to be transformed with bacteria and yeast DNA using pollen as a vector, in order to screen for transformation events.3 3 0

As the primary reviewer

of the proposal, RAC member and University of Wisconsin bacteriologist, Winston Brill, spoke in favor of the Cornell experiment when introducing it to the RAC.

Although Brill viewed it as having a low

probability of success, he had stated in a document of support for the project, ÒIt would take an imagination much greater than mine to dream up a dangerous outcome.Ó3 3 1 After a brief discussion at the October 25, 1982 RAC meeting, which focused mainly on concern about the use of antibiotic resistance as a means of evaluating successful transformation, a motion to recommend RAC approval passed by a vote of ten in favor, one opposed, and three abstentions.3 3 2 The USDA Recombinant DNA Committee (A-RAC) also considered the Cornell proposal during its own February 23, 1983 meeting.

USDA would concur with the RACÕs decision by unanimous

approval.3 3 3 By April of 1983, a notice in the Federal Register announced final approval for Dr. Sanford of Cornell to grow his tomato and tobacco 330

(48 FR 16459) Letter from Winston Brill to Stanley Barban, ORDA, dated July 14, 1982. RAC binder of materials for meeting of October 25, 1982, Tab #1080. Tolin Archive Box 23. 332 Minutes for RAC meeting of October 25, 1982, p.8 in U.S. Department of Health and Human Services, (1986). Documents Relating to "NIH Guidelines for Research Involving Recombinant DNA Molecules" September 1982 - September 1984, Office of Recombinant DNA Activities, NIH Publication No. 86-2863., pp.5-35. 333 Minutes of USDA Recombinant DNA Committee meeting, February 23, 1983. Tolin Archive, Box 3, Folder: Ò1978-1985 ... USDAÓ. 331

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plants in the field.3 3 4

As in the case of the Davis corn proposal of 1980,

there had not been a single comment received during the public notification period.3 3 5

Again as in the Davis corn case, the Cornell design

was another project never completed.3 3 6 In retrospect, the approval of the tomato/tobacco proposal, followed by lack of scientific fruition, may have made the exercise of getting RAC review seem pointless.

Nonetheless, the ritual served a valuable

purpose in that it induced the RAC members to ponder their need for more information about plants and agricultural methods before making revisions to the Guidelines that would affect agriculture. The RAC members knew that the NIH Guidelines had been framed with reference mainly to human health and human pathogens.

They

also recognized that the RAC would soon be likely to get many more requests for field testing of agricultural applications of rDNA, as advised by the Day letter (Chapter 4).

Thus, some members voiced concern

about their lack of botanical knowledge and asked where they might best obtain information on basic plant biology.

Several suggestions,

including the possible formation of a Working Group on Plants and Agriculture, were brought forth.

However, there was no time for

further discussion on the subject at that October 25, 1982 meeting.3 3 7

334

(48 FR 16459). April 15, 1983. Ibid. 336 In the Sanford case, transformation by pollen in greenhouse and growth chamber experiments had been unsuccessful, as Brill had predicted, thus the field tests were not conducted. From minutes of RAC Working Group on Release into the Environment meeting May 31, 1984, p. 5. Tolin Archive, Box #1, Folder: 9-3. 337 RAC meeting minutes of October 25, 1982, in U.S. Department of Health and Human Services, (1986). Documents Relating to "NIH Guidelines for Research Involving Recombinant DNA Molecules" September 1982 - September 1984, Office of Recombinant DNA Activities, NIH Publication No. 86-2863. See pp.5-29. 335

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The RACÕs education in agricultural affairs would have to wait until the following spring. Ice-Minus

A second notable request on the agenda of the October 25, 1982 RAC meeting was from Drs. Steven Lindow and Nicholas Panopoulos of U.C.Berkeley.

Lindow and Panopoulos requested approval to do outdoor

experiments with rDNA derived strains of Pseudomonas syringae and Erwinia herbicola.3 3 8 surfaces.

Both organisms are common inhabitants of plant

The wild type forms of these bacterial species produce a

protein that facilitates ice crystal formation.

Mutant forms, without the

ability to produce the ice-nucleating protein, exist naturally in small numbers or they can be induced by chemical means in larger quantities. Steven Lindow had discovered the role played by ice-nucleating bacteria in frost damage to plants while a graduate student at University of Wisconsin in the mid 1970s.

LindowÕs research was

partially funded by the private biotechnology firm, Advanced Genetic Sciences (AGS).3 3 9 Erwinia herbicola was later dropped from the protocol.3 4 0

338

Milewski, Elizabeth, (1987). ÒThe NIH Guidelines and Field Testing of Genetically Engineered Plants and MicroorganismsÓ in Application of Biotechnology: Environmental and Policy Issues. J. R. Fowle, III, Ed. Boulder, CO. Westview Press for the American Association for the Advancement of Science. pp. 55-90. See p.63, Table 3.3; Also Krimsky, Sheldon, (1987). ÒGene Splicing Enters the Environment: The Socio-Historical Context of the Debate Over Deliberate ReleaseÓ in A p p l i c a t i o n of Biotechnology: Environmental and Policy Issues. J. R. Fowle, III, Ed. Boulder, CO. Westview Press for the American Association for the Advancement of Science. pp. 27-53. See p.36. 339 Rogers, Michael, (1983). ÒGene Splicing Leaves the Lab.Ó N e w s w e e k. v. (August 15) p. 63. 340 Coincidentally, the genus E r w i n i a was named after the same Erwin F. Smith, acknowledged in Chapter Two for his work with crown gall. Krieg, N.R. and J.G. Holt, Eds. (1984). Bergey's Manual of Systematic Bacteriology Baltimore, MD,

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The proposed recombinant microorganisms were to be designed for the purpose of biological control of frost damage in plants.

They would

be carrying laboratory-generated deletions of all or part of the gene involved in production of the protein that facilitates ice nucleation.3 4 1 Although the recombinant forms were expected to have the same properties as the natural or chemically induced mutant forms, the rDNA forms were more stable and did not so easily revert back to the wild type.

The recombinant form, without the ice-nucleating gene, was

nicknamed ÒIce-Minus.Ó Although Ice-Minus was not the first rDNA release protocol to be approved by the RAC, it would become the first outdoor intentional release of rDNA microorganisms--eventually.3 4 2

Ice-Minus became a

Òposter childÓ for the rDNA release controversy by renewing media attention to rDNA, enlarging the extent of interest from the public, and by demonstrating the delays that can be experienced when pioneering a path through a complicated, bureaucratic, untested federal policy maze-all based on speculative hazard. In their proposal to the RAC, the Ice-Minus investigators described exactly what would be done and how. precautions and an emergency plan.

They described biosafety They provided extensive

information on work that had already been done and why this experiment was the next logical step.

They described two indoor

Williams & Wilkins. See pp.469, 473-474. 341 (47 FR 41924) See p.41925. Marc LappŽ presents an interesting analogy for how bacterial ice-nucleating protein works. In the making of rock candy, the addition of a single grain of sugar to a supersaturated sugar solution starts the cascade of crystal formation. LappŽ, Marc, (1984). Broken Code: The Exploitation of DNA. San Francisco, Sierra Club Books. at p.165. 342 The first release of Ice-Minus was in April of 1987, not by Lindow, but by the private company, Advanced Genetic Sciences (AGS) that co-sponsored LindowÕs

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locations and six different outdoor locations as testing sites.

Antibiotic

resistance would be used as a marker for monitoring purposes.3 4 3 RAC member, Winston Brill was again one of the principal reviewers for the project.

He introduced the U.C.-Berkeley proposal with his

recommendation that the proposal be approved.

One RAC member

asked if it were customary to field test organisms in so many locations simultaneously.

Another asked what ÒisolatedÓ meant in the context of

an agricultural testing area.3 4 4

Dr. Brill explained to his medically

trained colleagues the routine necessity in agricultural research for testing under a variety of environmental conditions before drawing any conclusions.

He also explained that test plots would be ÒisolatedÓ by not

conducting them near commercial growing areas for the same crop. Another question raised was about other roles that Pseudomonas syringae and Erwinia herbicola may fill in the ecosystem.

For example,

one RAC member wondered about the role of these organisms in precipitation patterns, given that they are found in the atmosphere and in clouds.3 4 5

It was pointed out that similar field tests with non-

recombinant ice nucleation deficient organisms were already being carried out, with no apparent negative consequences.

It was also

argued that using rDNA techniques was just another means of producing research. The AGS product was called ÒFrostban.Ó 343 The Ice-Minus protocol and request for permission to test, with supporting materials, is at Tab 1081, in the binder of materials for RAC meeting of October 25, 1982. Tolin Archive, Box #23. 344 David Martin, a professor of medicine, asked about the need for many locations. Elena Nightengale, a program officer at NAS Institute of Medicine, asked what constituted ÒisolationÓ in crops. Minutes of RAC meeting, October 25, 1982. See p.11. in U.S. Department of Health and Human Services, (1986). D o c u m e n t s Relating to "NIH Guidelines for Research Involving Recombinant DNA Molecules" September 1982 - September 1984, Office of Recombinant DNA Activities, NIH Publication No. 86-2863. See pp.5-35. 345 Pieter C. Wensink, a biochemist, noted the presence of ice-nucleating

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the same organisms.

131

Finally, by a vote of seven in favor, five opposed,

and two abstentions, the RAC narrowly approved the field tests.3 4 6 However, the RAC was only advisory to the NIH director, therefore its recommendations were not to be considered final.

Because of the

narrow margin of the vote and because some concerns remained unaddressed, the NIH director (then James Wyngaarden) withheld final approval.

A January 10, 1983 Federal Register notice announced that

the researchers Òmay bring this or a modified proposal back for consideration at a future RAC meeting and may at that time wish to submit additional data resulting from experiments conducted in the laboratory or greenhouse.Ó3 4 7 Clearly the Cornell tomato/tobacco and U.C.-Berkeley Ice-Minus proposals had served to alert the RAC members to their need to address seriously a means of reviewing agricultural applications of rDNA. Although the RAC would continue for several more years to be the only federal overseer for rDNA activities, the USDA was always in the background to provide advice.

NIH and USDA Collaboration The USDA had somehow acquired an undeserved reputation for inaction with respect to rDNA policy.3 4 8

At times, the development of a

rDNA policy that the agricultural community could live with seemed a long, slow, uphill battle. Yet, USDA persisted in allowing NIH to take the organisms in clouds. Minutes of RAC meeting, October 25, 1982 See p.11. Ibid. 346 Minutes for RAC meeting October 25, 1982, p.11 Ibid. 347 (48 FR 1156) See p. 1158. 348 For example, John Cohrrsen, formerly with the Reagan White House staff, commented in an interview that it had seemed to him USDA just was not interested in Ògrabbing any bureaucratic turfÓ regarding rDNA oversight. Interview with John Cohrssen, J.D. former legal counsel, Cabinet Council Working Group on

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I offer in partial explanation that agricultural scientists are by

their very nature patient people.

One can not hurry the gestation of a

cow or the growth of a crop from seed to harvest.

One can do little to

control the length of growing seasons or climatic conditions.

In

agricultural research, many tedious repetitions of experiments with many uncontrollable variables are required before meaningful results can be inferred.

Time and patience are the agricultural researcherÕs

tools of the trade. Although they purposely did not attempt to take the lead in rDNA oversight, preferring to treat rDNA as nothing special, it is not true that USDA did nothing. Personnel in CSRS, led by John Fulkerson, clearly believed that there should be one and only one set of federal rDNA Guidelines--the ones developed by the highly respected RAC. Duplication of oversight efforts would only waste money that could be spent on research instead.3 4 9

Many more rDNA deliberate release

protocols were expected to be submitted to the NIH for approval.

Thus,

USDAÕs A-RAC continued to work side by side with the RAC to revise the Guidelines so that agricultural researchers could benefit from the new technology.

(See Chapter Eight.)

Although the RAC and A-RAC advisory panels met separately, they coordinated discussions of similar, sometimes identical, issues and protocols.

There was a high degree of communication between them

during the early 1980s.

Liaison representation among various

Biotechnology, Reagan Administration. Washington, DC (December 19, 1997). 349 Memo from John Fulkerson, dated January 8, 1977, ÒSubject: Recomb. DNA Status/RecapÓ listed his views and opinions regarding rDNA. Tolin Archive, Box #3, Folder: 1978-1985 Important USDA Docs. Also, Personal communication with Sue A. Tolin, Ph.D. Professor of Plant Pathology, Physiology, and Weed Science, Former USDA representative to the NIH-RAC and OECD. Virginia Tech (various

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committees in different federal agencies is a fairly common phenomenon in Washington and provides a vital coordinating function. The two committees were able to keep apprised of proposals received and decisions made by each other because of liaison membership on both committees.

For example, Sue Tolin, from CSRS and Virginia Tech,

represented USDA and the Land Grant System on the RAC, while Dr. William Gartland, (Director, ORDA), served as the NIH liaison to A-RAC. By the early 1980s, the agricultural research community knew it would soon be ready for outdoor rDNA research.

The RAC was not.

The

RAC was effectively the only federal overseer of rDNA research, as the mainstream USDA research personnel preferred, but the majority of RAC members were not well versed in agricultural procedures nor in risks to hosts other than human beings.

There was a great deal of

uncertainty, and the threat of strict regulation of environmental release of rDNA, which could become unnecessarily restrictive or prohibitively expensive to agriculture, still loomed large. Revising RAC Guidelines for Release

When the RAC Working Group on Revision of the Guidelines met on January 21, 1983, the first item on the agenda was Òagricultural concerns, e.g., what constitutes dissemination into the environment for plants.Ó3 5 0

The working group chairperson asked Sue Tolin, liaison

representative from USDA, to introduce the topic.

dates in 1998, 1999). 350 Minutes of RAC Working Group on Revision of the Guidelines meeting, January 21, 1983, in U.S. Department of Health and Human Services, (1986). D o c u m e n t s Relating to "NIH Guidelines for Research Involving Recombinant DNA Molecules" September 1982 - September 1984, Office of Recombinant DNA Activities, NIH Publication No. 86-2863. See pp.68-76.

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Dr. Tolin explained procedures used by USDA as well as universities and private firms in collecting and transporting germplasm, in breeding programs, and in development of commercial strains.

She provided

information to the group on basic botany and genetics, and answered a multitude of questions about weeds, plant pathogens, and biological pest control.

Dr. TolinÕs presentation was supported by remarks from RAC

member, John Scandalios, a geneticist from North Carolina State University.3 5 1 The long list of questions and concerns presented in a single paragraph of the minutes of this Working Group meeting suggests that a lively and excited discussion continued even after the chairÕs suggestion that Drs. Tolin and Scandalios co-author proposed modifications to the Guidelines for presentation to the full RAC meeting in April, 1983.3 5 2 These discussions marked the beginning of a series of revisions which eventuated in two RAC Guideline documents that would later become very important to agriculture: ÒAppendix L, Release into the Environment of Certain PlantsÓ and ÒPoints to Consider for Submissions Under Appendix L.Ó Appendix L, which specified conditions under which certain categories of rDNA plants could be released into the environment without a full, detailed RAC review, began life as the Tolin-Scandalios proposal for revision to the Guidelines.3 5 3

At its February 23, 1983

meeting, the A-RAC provided advice and suggestions to Tolin for 351

Ibid. Ibid. 353 A history of the evolution of Appendix L and ÒPoints to Consider for Submissions Under Appendix LÓ documents is detailed in Milewski, Elizabeth and Sue A. Tolin, (1984). ÒDevelopment of Guidelines for Field Testing of Plants Modified by Recombinant DNA Techniques.Ó Recombinant DNA Technical Bulletin 352

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modifying the NIH Guidelines in order to facilitate approval of experiments requiring field testing.

A proposal for revision of the

Guidelines was drafted by Drs. Tolin and Scandalios (who together with Winston Brill constituted the Plant Working Group of the RAC) and was published in the Federal Register of March 4, 1983 for public comment.3 5 4 The Tolin-Scandalios proposal was in the form of a categorical exception to section III-A-2 of the August 27, 1982 version of the Guidelines.3 5 5

Although exceptions were possible to the general

prohibition of deliberate release of rDNA containing organisms into the environment, as the Guidelines stood, such protocols required RAC review plus both NIH and the investigatorÕs Institutional Biosafety CommitteeÕs (IBC) approval before initiation.

The new language in the

Tolin-Scandalios proposal would delegate more responsibility to the IBCs, and require only RAC notification if the experiments met certain criteria. Back at the USDA, at their March 23, 1983 meeting, the A-RAC discussed the in-progress Tolin-Scandalios proposal and endorsed the following standards for review of requests to release rDNA containing organisms into the environment: 1 . Field testing is necessary for proper evaluation of the performance potential of the plants. 2 . Release into the environment should be registered by the Office of Recombinant DNA Activities at NIH, and 3 . The local Institutional Biosafety Committees (IBC) should verify the inclusion in individual proposals of sufficient

( N I H ). v. 7(3) (September) pp. 114-124. 354 (48 FR 9436) See p.9441. 355 (47 FR 38048).

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detail as set forth by the generic (Tolin-Scandalios) proposal.3 5 6 In light of this proposal, which was of great interest to the agricultural community, and the NIH directorÕs reluctance to give final approval to the Ice-Minus proposal, the A-RAC recommended that a representative of the American Phytopathological Society be asked to attend the April 11, 1983 RAC meeting as an ad hoc advisor.3 5 7 Acceptance of Appendix L eventually revised the Guidelines by allowing approvals to be obtained by less cumbersome oversight procedures, provided certain very specific criteria were met regarding research organisms and methods.

Announcement of the final NIH approval of

Appendix L was published in the same Federal Register notice as the approval of the Ice-Minus protocol on June 1, 1983.3 5 8 High Profile Issues

Several high profile, high tension issues were on the agenda at the April 11, 1983 meeting of the RAC. public audience in attendance.

The meeting convened with a large

Major issues under consideration at this

meeting were: to respond to the report of the PresidentÕs Commission, Splicing Life, described earlier in this chapter; to examine the TolinScandalios revision of the Guidelines; and to review the Ice-Minus proposal for a second time.

In addition, the RAC had to consider still

more requests to relax the physical containment requirements to allow

356

Paraphrased from Minutes of A-RAC meeting, March 23, 1983. Tolin Archive, Box #3, Folder: 1978-1985 - USDA docs. 357 Minutes of A-RAC meeting, March 23, 1983. Tolin Archive, Box #3, Folder: 19781985 - USDA docs. 358 (48 FR 24548).

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the culturing of quantities of rDNA organisms sufficient for manufacturing purposes. The Tolin-Scandalios ÒgenericÓ proposal for field testing of certain plants containing rDNA was presented as a modification of the RAC Guidelines for environmental releases.

Drs. Tolin and Scandalios were

joined by Dr. Anne Vidaver, a plant pathologist from the University of Nebraska and a member of the American Phytopathological Society, who, following the suggestion of the A-RAC, had been invited to attend as an ad hoc advisor to the RAC.

Dr. Vidaver presented the Tolin-

Scandalious revisions. The plan was for Section III-A-2, the section prohibiting deliberate release into the environment of organisms containing rDNA, to be modified Òto except certain plants as described in (a new section) III-B4-c.Ó3 5 9

In brief, the language of the new section would have shifted

some review responsibilities to the local Institutional Biosafety Committees when certain criteria were met.3 6 0

The Tolin-Scandalios

proposal would ease the burden on the RAC, which would soon be getting many more proposals from agricultural investigators.

The

proposed revision would not have given blanket approval to all field

359

Minutes of RAC meeting, April 11, 1983, p.17 in U.S. Department of Health and Human Services, (1986). Documents Relating to "NIH Guidelines for Research Involving Recombinant DNA Molecules" September 1982 - September 1984, Office of Recombinant DNA Activities, NIH Publication No. 86-2863., pp.85-125 See p.102. 360 For example, if an investigator wanted to insert a well-characterized gene, even from a plant pathogen if the disease-causing sequences had been deleted, into a cultivated crop species of a genus that had no species known to be a noxious weed, using a Guidelines-exempt host-vector system, only IBC approval and n o t i f i c a t i o n of the RAC would be required. A Òwell-characterizedÓ gene is one for which the DNA base sequence is known. A Guidelines-exempt host-vector system is one which uses an NIH approved DNA recipient (the host) and means of transferring the DNA to that recipient (the vector).

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testing, but it would have simplified the oversight of many beneficial projects that were considered quite safe.3 6 1 The RAC set to work fine-tuning the proposal.

There was some

apprehension over the lack of specifications for ÒcontainmentÓ of the released organisms.

Some members were uncomfortable delegating too

much responsibility to the IBC and preferred to have either the full RAC or at least the RAC Plant Working Group review all experiments.

There

were also suggestions to remove the provision allowing the use of any plant pathogens at all or to allow use only of non-pathogenic portions or fractions of sequences.

Drs. Vidaver and Tolin, bacteriologist and plant

virologist respectively, countered that such a constraint would restrict research with plant viruses used as vectors, especially the Ti plasmidbearing A. tumefaciens, one of the most widely used organisms in agricultural biotechnology.

After extensive discussion, it was decided to

create a new appendix to the Guidelines; Appendix L, which would require Òreview and

approval of experiments both by the IBC and the

RAC Plant Working Group.Ó3 6 2 Ice-Minus was on the RAC agenda for a second time at the April 11, 1983 meeting.

As announced in the March 4, 1983 Federal Register, the

investigators had resubmitted a revised proposal, which addressed the issues that had been raised in the October, 1982 RAC meeting.3 6 3 The new proposal had reduced the list of test sites to one outdoor location: a 361

Minutes of RAC meeting, April 11, 1983, p.18 in U.S. Department of Health and Human Services, (1986). Documents Relating to "NIH Guidelines for Research Involving Recombinant DNA Molecules" September 1982 - September 1984, Office of Recombinant DNA Activities, NIH Publication No. 86-2863., pp.85-125 See p.103. 362 Milewski, Elizabeth and Sue A. Tolin, (1984). ÒDevelopment of Guidelines for Field Testing of Plants Modified by Recombinant DNA Techniques.Ó R e c o m b i n a n t DNA Technical Bulletin (NIH). v. 7(3) (September) pp. 114-124. See p.120. 363 (44 FR 9436).

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University of California Field Station at Tulelake in the northern part of the state.3 6 4

Dr. Ann Vidaver from the American Phytopathological

Society led the discussion of the revised Ice-Minus proposal.

This time,

the RAC recommended approval of the Ice-Minus proposal unanimously. On May 11, 1983 the Ice-Minus proposal was forwarded by William Gartland, Director ORDA, along with the Tolin-Scandalios proposal for revisions to the Guidelines, to the USDA A-RAC for review.3 6 5 In anticipation of the second review for Ice-Minus, the A-RAC had previously solicited advice from leading plant pathologists regarding the Lindow proposal.

A-RAC had received no negative comments as of their

March 23, 1983 meeting.3 6 6 Because the A-RAC had already discussed both the revised Ice-Minus and the Tolin-Scandalios proposals at its March meeting, A-RAC chairman, Clarence Grogan, responded with USDA endorsement of both proposals almost immediately.

Grogan added, ÒIt is hoped that the

National Institutes of Health mechanism for approval for such experiments can be expedited to allow investigators the opportunity to use this growing season for their experiments.Ó3 6 7

Clearly this instance

demonstrates that USDA was not dragging its feet in its attempt to clear an oversight path for the testing of rDNA agricultural projects. 364

Minutes of RAC meeting, April 11, 1983, p.23 in U.S. Department of Health and Human Services, (1986). Documents Relating to "NIH Guidelines for Research Involving Recombinant DNA Molecules" September 1982 - September 1984, Office of Recombinant DNA Activities, NIH Publication No. 86-2863., pp.85-125 See p.108. 365 Letter from William Gartland, NIH-ORDA to Clarence Grogan, dated May 11, 1983. Tolin Archive, Box #1; Folder: 6-2, Ò1983 A-RACÓ. 366 Minutes of A-RAC meeting, March 23, 1983. Tolin Archive, Box #3, Folder: 19781985 - USDA docs. (Recall that liaison membership in both panels provided ample opportunity for communication between the agencies.) 367 Response letter from Clarence Grogan to William Gartland, dated May 17, 1983.

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Subsequent to the resignation of NIH Director, Don Fredrickson, it fell to Dr. Richard Krause, Director of NIH-NIAID,3 6 8 to announce the final NIH approval of both the Ice-Minus experiment and the new Appendix L to the Guidelines in the same Federal Register notice on June 1, 1 9 8 3 .3 6 9

It was certainly a red-letter day for agricultural biotechnology.

But if the Ice-Minus investigators had broken open the champagne to mark their success, it would have been premature. Acquiring the ability to participate in decision making events is clearly important to any social group, whether scientists or lobbyists for social reform.

In this particular scenario, trained agricultural scientists

had been granted a place at the table with medical scientists, which enabled them to answer questions and thus to prevent the possible shaping of a policy that would have affected all agricultural scientists negatively.

Without specific knowledge of agricultural needs and

practices, the RAC may not have been able to make judicious choices for environmental research applications such as agriculture.

Yet, prior to

the approval of Ice-Minus, any meaningful input by the non-scientific public regarding the rDNA release issue was conspicuously absent. No public comments had been received regarding Ice-Minus following Federal Register announcements in September, 1982 and again in January, 1983.

By June 1, 1983, when the final RAC approval

was published, the receipt of only one public comment, a favorable one,

Tolin Archive, Box #1; Folder: 6-2, Ò1983 A-RACÓ. 368 NIAID is the National Institute for Allergy and Infectious Diseases. From 1979 to 1988, the Office of rDNA Activities and the RAC were located at NIAID. Becky Lawson, Director of Program Operations, NIH-ORDA, September 28, 1999, personal communication. 369 (48 FR 24548).

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had been acknowledged.3 7 0 publicÓ?

141

Where was the voice of the Òconcerned

In an interview, Sue Tolin recollected, ÒIt wasnÕt until after the

RAC approval of Ice-Minus that [the public interest groups] woke up. ThatÕs when unpleasant things really started happening.Ó3 7 1 A new threshold in the rDNA controversy had been crossed. had officially begun.

The Release Era

In the tense, late summer of 1983, critics of rDNA

technology took a stand that would postpone the testing of Ice-Minus for several years. One factor that made Ice-Minus so special was that the organism the investigators proposed to modify with rDNA and release into the environment was not a whole plant.

It was a live bacterium.

Although

only a very small percentage of the hundreds of thousands of species of bacteria are pathogenic, microorganisms do present a different sort of containment challenge.

Unlike whole plants, which are unlikely to

wander far from where they are rooted by researchers, it is possible for rDNA-containing microorganisms to emigrate undetected from test sites; in the wind, in drifting puddles of rainwater, or on the bodies of passing fauna.

Now that recombinant microorganisms were ready to leave the

lab, was society ready to accept them?

Summary Before the Release Era reached the threshold stage, the RAC was simultaneously considering the option of voluntary compliance, largescale production, and revisions to the Guidelines to allow outdoor agricultural experiments. 370

Meanwhile, external events, such as the U.S.

Ibid. Personal communication with Sue A. Tolin, Ph.D. Professor of Plant Pathology, Physiology, and Weed Science, Former USDA representative to the NIH-RAC and 371

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Supreme Court decision on patenting of life, and the unification of major religious leaders in favor of more oversight of rDNA, re-ignited public attention to rDNA. By 1982, Eli LillyÕs ÒHumulin,Ó a rDNA human insulin harvested from transgenic3 7 2 bacteria, became the first rDNA product approved for marketing.3 7 3

Not only were many more rDNA products in the pipeline

for testing and marketing, but the first three experimental protocols for the release of rDNA into the environment, which had come to the RAC between 1980 and 1983, had all been approved.

The pressing

anticipation of the release of rDNA organisms into the environment had made the impending widespread use of the technology, to the horror of some critics, a Òclear and present danger.Ó

At the same time, there were

those with a desire to move biotechnology rapidly from esoteric science to commercially viable technology. By the time Ice-Minus was approved in the summer of 1983, there was no doubt; the genie was out.

The only question remaining was this:

Who would be in charge of controlling the genie?

The uncertainty about

who would control what aspects of the federal rDNA oversight program led to a rebirth of conflict in the rDNA controversy with new arenas for political feuding during the Release Era. Critics seized the opportunity to repolarize the rDNA debate and bring it to the attention of the media and the general public once again. As the RAC seriously questioned its position as de facto regulator of OECD. Virginia Tech (various dates in 1998, 1999). 372 A ÒtransgenicÓ organism is one which has incorporated a piece of DNA from an organism of a different genus. A ÔgenusÕ is the taxonomic category immediately above species. In this case, the bacteria (Genus E s c h e r i c h i a) contained DNA coding for the insulin gene from a human (Genus Homo) . 373 Altman, L.K., (1982). Ò US Unit backs human insulin for the market.Ó N e w

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rDNA, House Democrats on Capitol Hill prepared an offensive against a Republican Administration which appeared unresponsive to public demands for more careful oversight.

The repolarization of the rDNA

controversy is the subject of the next chapter.

York Times. New York. October 30, p. A1.

CHAPTER SEVEN: WASHINGTON CIRCUS: 1983 Introduction In 1983, participants staked out their positions for the Release Era of the rDNA controversy.

As soon as rDNA technology became more than a

flight of fancy, it became absorbed into the Washington parlance.

The

Congress, federal agencies, and public interest groups had a unique opportunity to use the fashionable debate topic to advantage; and use it they did.

The Administration focused on international competitiveness.

Jeremy Rifkin, who represents the radical element of opposition in my account, became more active in the policy arena in 1983.

Some of

RifkinÕs activities will be introduced in this chapter, but a closer examination of his philosophy and activities will be presented in Chapter Ten.

Except for the Congress, which had substituted promotion

of public control of biotechnology for protection of the public from rDNA research, positions in the debate had changed very little from the previous Containment Era.

House Democrats and rDNA In the mid-1980s, several Congressional hearings provided a forum for various players to take a stand on the rDNA release issue.

One in

particular is worth examining in detail--the so-called Gore hearing and the resultant Gore Report-- because reactions to it so beautifully illuminated the repolarization of the debate.

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The Gore Hearing: June 22, 1983

On June 22, 1983, a joint hearing was held by two subcommittees of the House Committee on Science and Technology.3 7 4

The Subcommittee

on Investigations and Oversight and the Subcommittee on Science, Research, and Technology were chaired by Gore and Doug Walgren (DPA), respectively.

The hearing, entitled ÒThe Environmental

Implications of Genetic Engineering,Ó was convened for the purpose of addressing three questions, which I paraphrase here: 1 . What are the benefits and risks associated with deliberate release of rDNA organisms? 2 . Can the impact of deliberate release be predicted? and 3 . Is the existing regulatory framework adequate to assess risks and benefits and to permit the realization of benefits while minimizing the risks?3 7 5 Among the witnesses were representatives of academia, industry, and government.

On hand to describe his research activities was

Ananda Chakrabarty, who, thanks to the Supreme Court decision in his favor, had won his patent appeal on the oil-eating bacterium.

Steven

Lindow, who had just received NIH approval to field test his Ice-Minus bacteria, was also present to give testimony.

Representatives from the

NIH, EPA, and USDA described statutes that were already in place that might be useful in the regulation of the biotechnology industry, should

374

U.S. Congress, House of Representatives, Committee on Science and Technology, Subcommittee on Investigations and Oversight, et al., (1983). The Environmental Implications of Genetic Engineering. U.S. Government Printing Office. Washington, D. C. June 22. Hearing. 98/36. 375 U.S. Congress, House of Representatives, Committee on Science and Technology, Subcommittee on Investigations and Oversight, (1984). The Environmental Implications of Genetic Engineering (The "Gore Report"). U.S. Government Printing Office. Washington, D. C. February. Staff Report. Serial V.

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it become necessary.3 7 6

146

Frances Sharples, a terrestrial ecologist from

Oak Ridge National Laboratory who had completed a fellowship with the EPA in the previous year testified that Òecologists usually do not understand enough about the complex interactions in an ecosystem to be able to predict the [impact of an introduced organism] with any degree of certainty.Ó3 7 7

Because there had been no known releases of

rDNA up to that time, she had attempted to predict the risk of rDNA release by using the introduction of exotic species and the acquisition of antibiotic resistance by bacteria as study models. Although Congressman Gore supported the development of the biotechnology industry as an economically important entity, he was not happy with what he and his staff felt was inadequate public oversight of the release of rDNA into the environment.

They concluded that the

risks surrounding the issue of rDNA in the environment were difficult to define, but that they were likely to be of Òlow probability, high consequence.Ó3 7 8

Likewise, it would be Òextremely difficult, if not

impossibleÓ to predict Òthe specific type, magnitude, or probability of environmental effects associated with the deliberate release of genetically engineered organisms.Ó3 7 9 Regarding the adequacy of the existing regulatory framework for rDNA, GoreÕs Subcommittee staff report noted that ÒNo single agency or 376

U.S. Congress, House of Representatives, Committee on Science and Technology, Subcommittee on Investigations and Oversight, et al., (1983). The Environmental Implications of Genetic Engineering. U.S. Government Printing Office. Washington, D. C. June 22. Hearing. 98/36. 377 Sharples testimony in Ibid. See p.21. 378 U.S. Congress, House of Representatives, Committee on Science and Technology, Subcommittee on Investigations and Oversight, (1984). The Environmental Implications of Genetic Engineering (The "Gore Report"). U.S. Government Printing Office. Washington, D. C. February. Staff Report. Serial V. See p.9. 379 Ibid. See p.10.

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entity [possessed] both the expertise and authority to properly evaluate the environmental implications of releases from all sources.Ó3 8 0

With

respect to the oversight of release of rDNA products into the environment, the report listed the expertise of the RAC as ÒinadequateÓ, the Òscope and contentÓ of the EPAÕs effort as ÒunknownÓ, and the USDAÕs role as Òunclear because of its limited experience and disinclination toward oversight in this area.Ó3 8 1 High ranking agency witnesses at the hearing were not in complete agreement on the adequacy of federal oversight of rDNA, either.

Both

Bernard Talbot, Deputy Director of NIAID3 8 2 (representing NIH), and Edgar Kendrick, the Acting Deputy Assistant Secretary for SEA3 8 3 (representing USDA), testified that federal oversight was adequate.3 8 4 According to Talbot, even though the NIH Guidelines only covered NIH grantees, they could easily be, and in some cases had been, made mandatory by state and local statutes if necessary.3 8 5

Although

Kendrick identified several statutes under which USDA m i g h t be able to regulate rDNA under certain circumstances, he claimed that the agency 380

Ibid. Ibid. Emphasis added. 382 NIAID is the National Institute for Allergy and Infectious Diseases. 383 SEA is the Science and Education Administration, which was the branch of USDA in which the research divisions (such as CSRS) were located. The regulatory functions of USDA (such as APHIS) came under the Assistant Secretary for Marketing and Inspection. The research division had been reorganized several times during the period covered in this dissertation. By 1982, the directorship of SEA had become an Assistant Secretary level. 384 Testimonies in U.S. Congress, House of Representatives, Committee on Science and Technology, Subcommittee on Investigations and Oversight, et al., (1983). T h e Environmental Implications of Genetic Engineering. U.S. Government Printing Office. Washington, D. C. June 22. Hearing. 98/36. Talbot at p.111; Kendrick at p.140. 385 Ibid. at p. 115. For a sampling of early state and municipal ordinances regarding rDNA see Krimsky, Sheldon, (1979). ÒA Comparative View of State and Municipal Laws Regulating the Use of Recombinant DNA Molecules Technology.Ó Recombinant DNA Technical Bulletin. v. 2 (3) (November) pp. 121-125. 381

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took the position that additional regulation by USDA, beyond its support of the NIH Guidelines, was unnecessary.3 8 6 Only Don Clay, Acting Assistant Administrator, from EPAÕs Office of Pesticide and Toxic Substances (OPTS), outlined how EPAÕs statutes, FIFRA and TSCA, could be used to regulate most cases of release of rDNA organisms into the environment.3 8 7

Clay had to admit, however,

that EPA had neither the expertise nor the manpower to follow through.3 8 8 Clay asserted that the EPA was taking a proactive stance on the rDNA issue and that it was Òprepared to take a responsible role in evaluating, and to the extent necessary, controlling the products of biotechnology.Ó3 8 9

EPA had already considered forming its own

advisory group to serve the same function as the RAC, should the NIH cease its activities in that area.3 9 0 Another witness, Geoffrey Karny, a senior analyst with the Office of Technology Assessment, also addressed the statutes available with which to oversee biotechnology. 386

Although he listed USDAÕs statutes on

U.S. Congress, House of Representatives, Committee on Science and Technology, Subcommittee on Investigations and Oversight, et al., (1983). The Environmental Implications of Genetic Engineering. U.S. Government Printing Office. Washington, D. C. June 22. Hearing. 98/36. See p.145. 387 EPA-OPTS is the agency within EPA which administers FIFRA and TSCA. FIFRA is the Federal Insecticide, Fungicide, and Rodenticide Act, which Clay said could cover any rDNA products which were used as pesticides. TSCA, often referred to as the Ògap fillingÓ environmental law, could be stretched to cover most other rDNA product releases. FIFRA is at 7 USC 136 et seq. TSCA is at 15 USC 2601 et seq. 388 Testimony given by Don Clay, June 22, 1983. U.S. Congress, House of Representatives, Committee on Science and Technology, Subcommittee on Investigations and Oversight, et al., (1983). The Environmental Implications of Genetic Engineering. U.S. Government Printing Office. Washington, D. C. June 22. Hearing. 98/36. See pp.122-136. 389 Ibid. at p. 135. 390 Meeting minutes of the Large-Scale Review Working Group, September 9, 1981 in U.S. Department of Health and Human Services, (1982). Documents Relating to "NIH Guidelines for Research Involving Recombinant DNA Molecules" November 1980-August 1982, Office of Recombinant DNA Activities, NIH Publication No. 832604. See p.186.

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plant and animal quarantine, he admitted he knew little about them. He spent the greater part of his testimony discussing the merits of EPAÕs FIFRA and TSCA statutes, claiming that although no federal law clearly covered deliberate release of rDNA, TSCA had the greatest potential. ÒThe heart of TSCA,Ó said Karny, Òis the pre-manufacturing notice requirement for new chemical substances in section 5.Ó3 9 1 However, Karny indicated the necessity of redefining rDNA as a Ònew chemical substanceÓ in order for TSCA to apply.

At this point,

Congressman Gore pointed out a critical semblance to the Supreme Court decision in the Chakrabarty patent case.

The Supreme Court decision

had referred to ChakrabartyÕs organism as Òa n e w bacterium with markedly different characteristics from any found in nature.Ó3 9 2 Although patent laws had not been designed to cover living entities, the Supreme Court had held that patent law could be interpreted to cover them.

Therefore, Gore suggested that one might expect the courts to

uphold the argument that TSCA, which likewise was not specifically designed to cover living entities, should be able to cover them as well.3 9 3

391

Karny testimony at p.32 in U.S. Congress, House of Representatives, Committee on Science and Technology, Subcommittee on Investigations and Oversight, et al., (1983). The Environmental Implications of Genetic Engineering. U.S. Government Printing Office. Washington, D. C. June 22. Hearing. 98/36. 392 C h a k r a b a r t y, p. S-8. Emphasis added. 393 GoreÕs comment at p.32 in U.S. Congress, House of Representatives, Committee on Science and Technology, Subcommittee on Investigations and Oversight, et al., (1983). The Environmental Implications of Genetic Engineering. U.S. Government Printing Office. Washington, D. C. June 22. Hearing. 98/36..

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The Gore Report3 9 4

A staff report summarized the June 22, 1983 hearing and listed seven recommendations, which are reproduced in Appendix D.

The

report made clear that Gore and his staff believed that the EPA was the agency best suited to regulate the release of rDNA into the environment. However, they were quick to claim that their recommendation was Ònot to be taken as an endorsement of EPA action under TSCAÓ because of EPAÕs staff shortages, budgetary reductions, and lack of experience with rDNA.3 9 5 The first recommendation of the Gore Report was that the ÒEPA should proceed with its stated intention to extend its authority to include all deliberately released organisms not specifically identified as part of the legal obligation of another agency.Ó3 9 6

Because of the Ògap-

fillingÓ nature of EPAÕs TSCA statute, the Subcommittee felt that no additional legislation would be necessary at that time. For the purpose of evaluating federally funded proposals, the report recommended that the RAC, and the A-RAC, revise their respective memberships to include Òindividuals specifically trained in ecology and the environmental sciencesÓ for the purpose of evaluating proposals by federally funded investigators.3 9 7

However, exhibiting concern that the

voluntary compliance concept represented an opportunity for industry to escape public oversight, the Gore Report also recommended that the

394

U.S. Congress, House of Representatives, Committee on Science and Technology, Subcommittee on Investigations and Oversight, (1984). The Environmental Implications of Genetic Engineering (The "Gore Report"). U.S. Government Printing Office. Washington, D. C. February. Staff Report. Serial V. 395 Ibid., at p.50. 396 Ibid., at p.11. 397 Ibid., at pp. 12, 49.

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ÒNIH should cease its practice of evaluating and approving proposals for deliberate releases from commercial biotechnology companiesÓ and that a federal interagency task force should be instituted to review all deliberate release proposals Òuntil such time as EPAÕs regulations are promulgated.Ó3 9 8 It was stipulated that the interagency group would educate and inform the populace with meetings open to the public and that it would publicize both the facts of and basis for its decisions, but there was no mention of how, or whether, confidential business information would be kept confidential.

Additionally, it was recommended that the lead

agency in the interagency effort should be none other than the EPA. This represented a clear message from the environmentally conscious Representative Gore to the conservative Administration to stop pushing rDNA out the door without full public disclosure or before the EPA had the resources to regulate it.

It also represented a liberal perspective

that calls for greater public accountability, especially, though not only, when public funds are employed.3 9 9 The recommendation that an interagency task force be instituted was curious, because there already was such a body, although it had apparently gone dormant after President Reagan took office in 1981.4 0 0 The Federal Interagency Committee on Recombinant DNA Research (IAC) had been created in response to a 1976 letter to President Gerald Ford from Senators Edward (Ted) Kennedy (D-MA) and Jacob Javits (RNY) recommending Òexecutive action to extend the scope of the NIH

398 399 400

Ibid., at p.12. My own interpretation. Minutes of A-RAC meeting, January 24, 1984.

Tolin Archive, Box # 1, Folder 6-3.

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Guidelines to the rest of the public and private sectors.Ó4 0 1

152 In a 1976

White House memo, President Ford referred to the establishment of the Interagency Committee (IAC).4 0 2

The IAC, membership of which crossed

at least sixteen federal agencies, had had its first meeting on November 4, 1976, soon after the NIH Guidelines had been released.4 0 3 They continued to meet regularly until at least late in 1980 and appeared to have covered all topics recommended by the Gore Report except for release into the environment, which had not yet become an imminent issue.4 0 4

In view of the IACÕs dormancy during the Republican Reagan

Administration, Democrat Gore apparently felt the need to prod the Executive Branch back into action. Perhaps because some agencies within USDA spurned the idea of using its existing statutes to regulate the release of rDNA into the environment, the Gore Report also recommended a General Accounting Office (GAO) review of USDAÕs activities in the area; in other words, an audit.4 0 5

The order was sent to the GAO by Congressman Don Fuqua (D-

FL), Chairman of the House Science and Technology Committee, on March 29, 1984.4 0 6 401

It is interesting to note that the ordering of a GAO

Minutes of first meeting of the Federal Interagency Committee on Recombinant DNA Research, November 4, 1976, page 2. Tolin Archive, Box #4; Folder FKN-112. 402 White House memo from Gerald R. Ford to the Heads of Departments and Agencies, dated September 22, 1976. Tolin Archive: Box #4, File: FKN-111. 403 Minutes of first meeting of the Federal Interagency Committee on Recombinant DNA Research, November 4, 1976. Tolin Archive, Box #4; Folder FKN-112. 404 Meeting notices for Industrial Practices Subcommittee of the Federal Interagency Committee on Recombinant DNA Research. Tolin Archive, Box #4; Folder: FKN-117. 405 U.S. Congress, House of Representatives, Committee on Science and Technology, Subcommittee on Investigations and Oversight, (1984). The Environmental Implications of Genetic Engineering (The "Gore Report"). U.S. Government Printing Office. Washington, D. C. February. Staff Report. Serial V. See p.12. 406 U.S. General Accounting Office, (1985). Biotechnology: The U.S. Department of Agriculture's Biotechnology Research Efforts. GAO. Washington, DC. October. Briefing Report to the House Committee on Science and Technology. GAO/RCED-86-

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audit is sometimes useful as a means of reprimand when no other punishment is justified. Reaction to the Gore Report

It is not insignificant that the Gore Report was in large part produced by Morris Levin, an EPA employee who was working with GoreÕs Subcommittee.4 0 7

At the time, Levin was on sabbatical from EPA where

he was Director of the Innovative Research Program.4 0 8

Levin was also

the EPAÕs non-voting liaison representative to the RAC throughout this period, providing a three-way communication link. John Fulkerson, principal scientist at CSRS, asserted that Levin was Òdirectly involved in building EPAÕs program to exert jurisdiction over [rDNA],Ó while he was Òon leave with GoreÕs committee, putting together all the testimony on this subject.Ó4 0 9

The implication was that there was

a cooperative liaison between the EPA and the House of Representatives developing of which Fulkerson did not approve.

The alliance between

EPA and the Congress to keep close watch over RAC activities would become reinforced when Frances Sharples, a former EPA fellow, later

39BR. See p.1. 407 It is customary for Members of Congress to thank staffers publicly who have done the bulk of the work on a project. Representative GoreÕs letter of transmittal for the report extended his Òappreciation to Dr. Morris Levin, a LEGIS Fellow currently on assignment to the Investigations and Oversight Subcommittee, for his assistance in preparing this report.Ó U.S. Congress, House of Representatives, Committee on Science and Technology, Subcommittee on Investigations and Oversight, (1984). The Environmental Implications of Genetic Engineering (The "Gore Report"). U.S. Government Printing Office. Washington, D. C. February. Staff Report. Serial V. See p.iv. 408 LevinÕs position at EPA is listed in the RAC roster accompanying the minutes of the April 11, 1983, RAC meeting. 409 Memo from John Fulkerson, principal scientist at CSRS, to Ed Kendrick, the Acting Assistant Secretary for USDA-SEA and chairman of the A-RAC, dated November 15, 1983. Tolin Archive, Box # 1, Folder 6-2.

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replaced Morris Levin, not only on GoreÕs staff, but, at GoreÕs insistence, as a full voting member of the RAC.4 1 0 Winston Brill, a member of the RAC until June 30, 1983, charged in an April 24, 1984 letter that the Gore Report, Òincorrectly prejudice[d] the reader to be concerned that the magnitude of potential problems that may be caused by releasing genetically engineered organisms to the environment is great.Ó4 1 1

Brill reproached the writers for relying on

Òincorrect scientific experiments,Ó Òirrelevant model systems,Ó and for their Òignorance of systems that are relevant to safety questions regarding release of such organisms.Ó The Òincorrect experimentÓ in question was a 1977 New Zealand trial by Giles and Whitehead in which two harmless organisms were combined in a way which yielded an organism pathogenic to pine seedlings.4 1 2

Brill characterized the work as Òfar from being accepted in

the scientific communityÓ and called the SubcommitteeÕs reliance on it as ÒIRRESPONSIBLE in light of a 1980 paper in which it was stated that

410

Letter from Congressman Al Gore to NIH Director, James Wyngaarden, dated October 21, 1983. Tolin Archive, Box # 1, Folder: 1-3. Sharples joined the RAC on June 1, 1984. At the RAC Working Group on Release into the Environment, October 5, 1984, Dr. Levin reported that Dr. Sharples was also a member of GoreÕs subcommittee. Meeting minutes, p.14. in U.S. Department of Health and Human Services, (1986). Documents Relating to "NIH Guidelines for Research Involving Recombinant DNA Molecules" September 1984 - March 1985, Office of Recombinant DNA Activities, NIH Publication No. 86-2864. See p.24. 411 Letter dated April 24, 1984, with 9 page comment document attached, from Winston Brill, Vice President and Director of Research of Cetus Madison, to Robert Nicholas, GoreÕs Chief Counsel and Staff Director for the Subcommittee on Investigations and Oversight of the House Science Committee. Tolin Archive, Box # 1, Folder 3-1. 412 Giles, K.L. and H.C.M. Whitehead, (1977). ÒReassociation of a Modified Mycorrhiza with the Host Plant Roots (Pinus radiata) and the Transfer of Acetylene Reduction Activity.Ó Plant and Soil. v. 48 pp. 143-152.

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more controlled experiments showed that the genetic modification played no role in seedling death.Ó4 1 3 Brill also called the reportÕs reference to the model of exotic pests such as kudzu and gypsy moth, ÒirrelevantÓ to rDNA organisms, in which only Òminor genetic changesÓ would be made Òin a plant that does not now cause environmental problems.Ó4 1 4

The Subcommittee had used

the introduction of exotic species model, admittedly, because no better one existed. The Brill letter reads more like a legal brief than a scientific opinion, because it presented the strengths of the minimum oversight argument in the best possible light, while glossing over the SubcommitteeÕs concerns about possible risks with phrases like Òextremely rare,Ó Òshould behave, (emphasis added),Ó and Òsurely these benefits far outweigh imagined risks.Ó

One of his examples follows:

Ò[Imagine a personÕs having purchased a lawnmower kit.] That person notes the similarity between the lawnmower and a helicopter--both are fueled by gasoline, both are made of steel, and both have rotary blades. What is the chance that the lawnmower, if assembled incorrectly, will fly up and crash in the busy school playground? Should the lawnmower manufacturer have tested the flying ability of incorrectly assembled machines?4 1 5 It is possible, though unlikely given his experience in Washington, that Brill really did not grasp the political motivation behind the Gore 413

Brill to Nicholas, April 24, 1984, p.6; All emphasis original; Tolin Archive, Box # 1, Folder 3-1. The 1980 paper to which Brill referred was by one of the same authors as the original New Zealand study. See Giles, Kenneth L. and Indra K. Vasil, (1980). ÒChapter 13: Nitrogen Fixation and Plant Tissue CultureÓ in International Review of Cytology, Supplement 11B, Academic Press. p. 81+. See p.94. 414 Brill to Nicholas, April 24, 1984, p.3; Emphasis original; Tolin Archive, Box # 1, Folder 3-1.

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maneuver and was simply reacting to what he perceived to be a lack of scientific understanding.

At best, BrillÕs use of ludicrous examples to

accentuate the ignorance of the critics of release of rDNA illustrated his extreme frustration with their slippery slope prophecies of doom.

At

worst, it demonstrates his skillful use of rhetoric to reduce the standing of his political opponents by making them look foolish, in order to block the path toward more restrictive federal control of rDNA technology development. The Brill letter, packed with examples of the benefits of rDNA over traditional agricultural techniques, was distributed by John Fulkerson, also a strong supporter of minimum oversight, with the following cover letter: COLLEAGUES ÒAttached is a most important document, not only for our initiative in new biotechnology in agriculture, forestry, and natural resources, but also for these interests broadly. It has been well received in USDA, NIH, NSF, FDA, etc. It should prove helpful to EPA.4 1 6 It is not surprising that BrillÕs document had been well received in USDAÕs CSRS, and in NIH, NSF, and FDA, because those were agencies which, in harmony with the Reagan Administration, supported minimal oversight of rDNA.

That the Brill document was described as potentially

ÒhelpfulÓ to the one agency which was known to be the main proponent of more rigorous oversight is perhaps indicative of FulkersonÕs charitable sense of humor.

As might be expected, EPA Administrator,

William Ruckleshaus, had found the Gore Report Òan insightful analysis 415

Brill to Nicholas; April 24, 1984, p.6; Tolin Archive, Box #1, Folder 3-1.

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which the [EPA] finds valuable in the development of its biotechnology program.Ó4 1 7

On the other hand, Henry I. Miller, the FDA liaison

representative to the RAC (and a staunch believer that rDNA did not deserve special regulatory attention) publicly characterized the Gore Report as ÒamateurishÓ.4 1 8 Other Congressional Messages to the Administration

John Dingell, chairman of the House Committee on Energy and Commerce, was also following the rDNA debate carefully.

In a letter

dated September 26, 1983 to James Wyngaarden, Director of the NIH, Dingell accused the NIH of acting Òin a manner that indicates that [its] voluntary program has the power to regulate and permit releases into the environment.Ó4 1 9

In light of the NIHÕs original development of the

Guidelines in order to p r e v e n t the accidental escape of the same kinds of organisms, DingellÕs letter contained a demand that the NIH Òrefrain from further decisions on releases of organisms until these issues have been adequately addressed by the Congress and until a system adequate to protect the public health is in place.Ó4 2 0 Also, on November 3, 1983, Congressman James Florio (D-NJ), a member of the House Investigations and Oversight Subcommittee of the House Energy and Commerce Committee, introduced legislation, H.R.

416

Fulkerson memo to Colleagues; May 4, 1984; Tolin Archive, Box #1, Folder 3-1. Letter from William Ruckleshaus to Congressman Al Gore, Jr., dated May 18, 1984. Tolin Archive, Box #1, Folder: 6-4. 418 Minutes from the October 5, 1984 RAC meeting, p. 14 in U.S. Department of Health and Human Services, (1986). Documents Relating to "NIH Guidelines for Research Involving Recombinant DNA Molecules" September 1984 - March 1985, Office of Recombinant DNA Activities, NIH Publication No. 86-2864. See p.24. 419 Letter from John Dingell to James Wyngaarden, dated September 26, 1983. Tolin Archive, Box #3, Folder: Dingell/Kendrick Ô83-Õ84. 420 Ibid. 417

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4304, with the short title, ÒToxic Substances Control Act Improvements Amendments of 1983,Ó that specifically would have put EPA in charge of rDNA.

FlorioÕs bill would have amended the Toxic Substances Control

Act Òto include any microorganism or other biological substance under the definition of Ôchemical substance.ÕÓ

Although the bill had only one

cosponsor and died in committee, it served as a signal to the EPA that it had a friend in FlorioÕs office as well.

That signal may have been

viewed by the ambivalent NIH with mixed feelings of relief. Representative Al Gore, Jr. was not opposed to the experimental release of rDNA, but he was cautious in his preferred approach to oversight, especially where environmental protection was concerned. In an October 21, 1983 letter to NIH Director, James Wyngaarden (and perhaps as a consequence of Jeremy RifkinÕs successful preliminary injunction against Ice-Minus - see next section), Gore urged that terrestrial ecologist, Frances Sharples, be appointed to the RAC Òas expeditiously as possible.Ó4 2 1

Dr. Sharples was a former EPA Fellow who

had testified at his June 22, 1983 Subcommittee hearing.

Gore

expressed a slight annoyance that Dr. SharplesÕ nomination had been left Òpending for several monthsÓ without action. 4 2 2

In addition, Gore

wanted a microbial ecologist assigned to the panel.

His letter reiterated

a concern that the RAC had no legal basis for reviewing requests for deliberate release from private biotechnology firms, nor did it have a formal procedure in place for adequate risk assessment.

Clearly,

Gore

was positioning himself to become an important player in the rDNA controversy. 421

Letter from Congressman Al Gore to NIH Director, James Wyngaarden, dated October 21, 1983. Tolin Archive, Box # 1, Folder: 1-3.

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In a letter of response to the congressman, NIH Director James Wyngaarden agreed to the panel appointments, but reminded Gore that during the first session of the 95th Congress (1977) after the NIH Guidelines were established, Òsixteen different bills on the topic of recombinant DNA were introducedÓ yet even after extensive hearings, Òno law on the subject passed.Ó4 2 3

There is an implication in the letter

that if the Congress had not seen fit to provide a legal basis for regulating the use of rDNA by private firms, Òvoluntary complianceÓ through peer review of proposals was the next best thing.

Critics Rally Against rDNA After an exasperating schedule of applications, resubmissions, and cross-examination of its developer by a Congressional Subcommittee, Ice-Minus now faced its most difficult challenge yet--the public interest group as litigant.

Because many of the judicial actions against rDNA

involved one particular statute, a brief digression is necessary to describe the significance of National Environmental Policy Act of 1969 (NEPA).4 2 4 Pursuant to NEPA, the NIH had been required to undertake an environmental assessment to evaluate the impact of the original RAC Guidelines before they were promulgated.

However, the protection to

the public provided by the Guidelines was considered so important that they were released a full three months before the required

422

Ibid. Letter from NIH Director, James Wyngaarden, to Congressman Al Gore, dated November 28, 1983, in response to GoreÕs letter of October 21. RAC document #1126. Tolin Archive, Box # 1, Folder 1-3. 424 NEPA is at (42 USC ¤4321 et seq, 1969). 423

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160

Thus, the NIH created a

basis for lawsuits against them. An environmental activist group, Friends of the Earth, took advantage of this turnaround of established procedure to bring suit in Federal District Court of New York on May 9 of 1977 against Department of Health, Education, and Welfare (HEW) Secretary Joseph Califano.

A

few weeks later, another suit was filed on a separate matter against Secretary Califano by trial attorney, Ferdinand Mack, for an injunction to prevent NIH from conducting a risk assessment study involving polyoma virus near his home in Frederick, Maryland. claimed that NEPA had been violated.4 2 6

Both suits

Neither plaintiff prevailed.

Trying to change from a total prohibition on release of rDNA to allowing exceptions without first having done an environmental assessment on the protocol itself would have constituted a second violation of NEPA.

The Environmental Defense Fund (EDF), was the first

to suggest that an environmental impact statement would be appropriate before approving such experiments.

On August 22, 1980

the EDF had sent a letter to Director Fredrickson requesting that the NIH prepare an environmental impact statement (EIS) on Ron DavisÕ (Stanford University) proposed corn experiment.4 2 7 The EDF emphasized that they did Òn o t object either to the experiment per se or

425

Publication of the RACÕs draft environmental impact statement is at (41 FR 38426). 426 Perpich, Joseph G., (1982). ÒIndustrial Involvement in the Development of NIH Recombinant DNA Research Guidelines and Related Federal PoliciesÓ in Recombinant DNA Technical Bulletin. U.S. Department of Health and Human Services, Ed. Washington, DC. NIH Publication No. 82-99. pp. 59-79. See pp.65-66. 427 Letter, dated August 22, 1980, from Maureen Hinkle, Pesticides Monitor, on behalf of the EDF to Donald Fredrickson, with copies noted to William Gartland, Jane Setlow, and Sue Tolin. Tolin Archive. Box #10, Folder: EA-Corn-1980-81.

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to the desirable goal of increasing protein in corn.Ó4 2 8

In fact, the letter

offered Òpraise [for] the scientist proposing this experiment for his imagination and persistence in the face of difficulty in obtaining funds and approvals.Ó

The EDFÕs stated purpose in asking for the EIS was to

Òanticipate secondary effects ... ahead of timeÓ in order to Òminimize potential negative impacts of technologies going awry.Ó4 2 9 EDFÕs polite, non-threatening request was apparently rejected without comment by the NIH director. These actions pre-dated the more famous lawsuits against environmental release of rDNA which were filed by anti-biotechnology activist, Jeremy Rifkin, throughout the 1980s.

Krimsky called Rifkin

Òthe czar of genetics litigationÓ and listed twelve cases filed against government agencies by Rifkin between the years 1983 and 1987.4 3 0 Many of RifkinÕs cases were based on NEPA and claimed that environmental impact assessments or environmental impact statements had not been published prior to actions taken.

RACÕs Biggest Backer - USDA By the September 19, 1983 RAC meeting, USDA was still trying to avoid having to take on regulatory responsibility for approval of release issues by pushing the RAC toward providing sections appropriate for USDA in the Guidelines.

Only a few months after Appendix L for plants

had been officially adopted, there was already a proposal to amend it in several ways.

For example, members of the RACÕs

Plant Working Group

felt that Appendix L should allow the use of DNA sequences that caused 428 429 430

Ibid. Emphasis original. Ibid. Krimsky, Sheldon, (1991). Biotechnics and Society: The Rise of Industrial

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plant disease (previously prohibited), because such sequences might be necessary in order to introduce the recombinant DNA into the plant.4 3 1 The proposal was to allow the use of disease causing sequences in developing the plants provided the plants were free of sequences that caused disease symptoms before release.4 3 2 The following month, at the A-RAC meeting of October 19, William Gartland, the liaison representative from the RAC, Òexpressed concerns that some of the proposals presented to the RAC [were] outside the purview of NIH, which is biomedical researchÓ and requested that Òthe USDA might consider sharing responsibilities with NIH in reviewing and approving agriculture-related proposals.Ó4 3 3

A-RAC members quickly

rejected the idea of having two parallel advisory boards.

They agreed

that there should be only one agency overseeing rDNA activities, and that one agency should be the NIH.

USDA was happy to provide

consultation, but supported no changes to the current system of review.4 3 4

David MacKenzie, formerly at CSRS recalled,

G e n e t i c s. New York, Praeger. See p.121 and Table 7 on pp. 122-123. 431 Minutes of the RAC meeting, September 19, 1983, p. 7-9; in U.S. Department of Health and Human Services, (1986). Documents Relating to "NIH Guidelines for Research Involving Recombinant DNA Molecules" September 1982 - September 1984, Office of Recombinant DNA Activities, NIH Publication No. 86-2863. See pp.191-193. See also (48 FR 37198). National Institutes of Health. (1983). ÒRecombinant DNA Research; Proposed Actions Under Guidelines and Advisory Committee Meeting.Ó Federal Register v. 48: 37198-37199. August 16. Acceptance of the amendments to Appendix L was announced on November 23, 1983. (48, FR, 53056). 432 Minutes of the RAC meeting, September 19, 1983, p. 7-9; in U.S. Department of Health and Human Services, (1986). Documents Relating to "NIH Guidelines for Research Involving Recombinant DNA Molecules" September 1982 - September 1984, Office of Recombinant DNA Activities, NIH Publication No. 86-2863. See p.191-193. 433 Minutes of A-RAC meeting of October 19, 1983. Tolin Archive, Box # 1, Folder 62. 434 Ibid.

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ÒThere was a strong push by the Fulkerson contingent [CSRS] to [get NIH to cover release of rDNA.] But when the Ice-Minus regulatory question hit NIH, they felt they didnÕt want any part of it because they could see it was a mess. ... What Lindow proposed to do didnÕt deal with any [human] pathogens. ... The whole paradigm was unraveling because the underlying premise of the NIH Guidelines was human pathogenicity. ... The issue [of] release into the environment [was] a whole different paradigm in a whole different direction and NIH, I think quite rightly said to us, ÔWe canÕt handle this. This is outside our domain. Here, you take it.Õ 4 3 5 According to MacKenzie, it was very unclear how oversight of agricultural rDNA release was going to be handled. ÒIt was going back and forth because Orville Bentley, who was the Assistant Secretary [of the research side of USDA], was being pushed by John Fulkerson to get NIH to extend their guidelines. And Sue Tolin spent endless hours writing Appendices to the NIH Guidelines, she wrote about greenhouses, field testing, Appendix L, M, N... When that didnÕt work Fulkerson started asking Bentley to set up USDA guidelines for field testing. At about the same time, APHIS [the regulatory arm of USDA] was looking at using its regulatory power to try to provide biosafety assurance under the Plant Pest Act.Ó4 3 6 Once APHIS became involved, internal strife would seriously disrupt the USDAÕs approach to biotechnology.

This intra-agency conflict will be

explored in Chapter Eight.

435

Interview with David MacKenzie, Ph.D. Executive Director, NE Regional Assn of State Agr. Experiment Stations, formerly with CSRS, USDA. Washington, DC (December 9, 1997). Emphasis is MacKenzieÕs. 436 Ibid.

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EPA Makes a Play for Oversight of rDNA Shortly after the June 22, 1983 Gore hearing, news spread that the EPA had Òdecided to take over the regulation of the gene engineering industry.Ó4 3 7

If a rDNA product could be defined as a ÒnewÓ chemical

substance, i.e., one that is not naturally occurring and which was not in existence in commercial quantities at the time EPA compiled its inventory of substances in commerce in the late 1970s, EPA could assert jurisdiction over rDNA using the TSCA statute.4 3 8 EPA officials met with the A-RAC on November 8, 1983 in an attempt to coordinate regulatory control of experimental release of rDNA into the environment.4 3 9

At the meeting, EPA announced that their Office of

General Counsel had ruled that Ice-Minus was a pesticide, and thus subject to regulation under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

The ÒpestÓ it was designed to control, (actually,

to displace by competing for the same ecological niche), was the wild type Pseudomonas syringae that had ice nucleation capability.4 4 0 437

Hilts, Philip J., (1983). ÒEPA to Regulate Gene Engineering Firms.Ó Los Angeles Times. Los Angeles. August 10, p. I.19. 438 Keystone Center, (1989). Keystone National Biotechnology Forum Interim Summary Report: An Analysis of the Federal Framework for Regulating Planned Introductions of Engineered Organisms. The Keystone Center. Keystone, CO. February. Includes a section entitled "Complete Regulatory and NIH Guidelines Analysis". See p.21. 439 Minutes of A-RAC meeting, November 8, 1983. Tolin Archive, Box #1, Folder: 62. EPA Administrator, William Ruckleshaus, had previously sent an invitation/request to Agriculture Secretary, John R. Block, asking USDA to join EPA and other agencies in forming a high level risk management group. Letter dated September 21, 1983. Tolin Archive, Box #1, Folder: 6-2. The documents concerning RuckleshausÕ proposal were presented to the A-RAC by APHIS representative Robert Kahn at its October meeting. Minutes of the A-RAC meeting, October 19, 1983; Tolin Archive, Box #1, Folder: 6-2. 440 Personal notes taken by Sue Tolin at meeting of A-RAC, November 8, 1983. Tolin Archive, Box # 1, Folder 6-2. A letter from John A. Moore, Assistant Administrator for Pesticides and Toxic Substances, EPA, to John W. Kennedy (probably an attorney for Microlife Technics), dated April 6, 1984 also identified Ice-Plus as the Òpest.Ó He wrote, ÒEPAÕs General Counsel has determined that ice nucleation

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Elizabeth Milewski, now Special Assistant for Biotechnology at EPA recalled, ÒSome people have gotten it wrong; they think that EPA thought that ice or frost was the pest, but the pest was the ice-plus, because that's what has the nucleation property that causes the ice crystals to form and damage the plant. 4 4 1 Regardless of whether Ice-Minus was meant to control ice-plus or ice itself, once EPA found a way to define it as a pesticide, no outdoor test could go forward until EPA had reviewed it, even though NIH had given approval.4 4 2

Getting EPA approval would require the Ice-Minus project

to suffer the delay of two more years of bureaucracy. Ironically, the mirror image of Ice-Minus was perceived as no threat to humans or the environment.

ÒSno-Max,Ó is a form of the same

organism (Pseudomonas syringae) genetically engineered to produce m a x i m u m amounts of the ice nucleating protein for use in making artificial snow.

The rDNA organisms are sprayed out into the

negative bacteria when used for reducing populations of ice nucleation positive bacteria would be a pesticide.Ó Tolin Archive, Box # 1, Folder 6-4. See also LappŽ, Marc, (1984). Broken Code: The Exploitation of DNA. San Francisco, Sierra Club Books. See p.167 for discussion of EPAÕs rationale for designating Ice-Plus the ÒpestÓ that might be prevented from colonizing plants by the ÒpesticideÓ IceMinus. EPAÕs decision to regulate Ice-Minus as a pesticide was also reported in Fishbein, Gershon W., ed., (1983). ÒBill Would Give EPA Authority over Biotechnology Products.Ó Genetic Engineering Letter. v. 3. (2) November 24. p. 1. 441 Interview with Elizabeth Milewski, Ph.D. formerly on staff at NIH-ORDA, presently Special Assistant for Biotechnology, EPA. Washington, DC (December 5, 1997). 442 The frost-as-pest story was an interesting rumor which may never be sorted out. Under ReaganÕs mandate of Òno new regulationsÓ if EPA officials wanted to regulate rDNA, they would have been forced to reinterpret the statutes they already had in order to fit products of biotechnology. If anyone at any time had suggested that frost was the pest that Ice-Minus had been designed to control, (perhaps during a brainstorming session in order to find a way to make an illfitting statute serve the purpose they wished it to serve), a competitor might have considered it worth perpetuating such a rumor in order to make the EPAÕs attempt to grab a piece of the regulatory pie look foolish.

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environment at many of the nation's ski areas that make artificial snow.4 4 3

ÒSno-MaxÓ was field tested by AGS, the same company that

supported the development of Ice-Minus, in about 1981.

However, it

did not require review by the EPA because, as a snow making enhancer, it was not subject to any registration requirements.4 4 4

Even though a

New York Times article reported that a trial run at Breckenridge had yielded poor results because of high winds that swept many of the rDNA organisms away,4 4 5 (possibly toward agricultural fields where the organism would have been a potential pest), the material was not considered hazardous enough to trigger federal oversight or containment

requirements.

Reactions to EPAÕs Move Forward Agricultural researchers were, without a doubt, agitated by EPAÕs contrivance to take on rDNA release regulation.

On August 16, 1983 a

message indicating some USDA concern about EPAÕs ÒtakeoverÓ was sent from Roy Lovvorn, Acting Administrator of CSRS, to Orville Bentley, the Assistant Secretary for SEA.4 4 6

Although the memo indicated that USDA

intended to cooperate with EPA, the tone of the memo was apprehensive.

Lovvorn alerted Bentley that, ÒNo special harm might be

done by EPA unless there is a claim of uniqueness.Ó4 4 7 Any claim of ÒuniquenessÓ was of particular concern to agricultural molecular biologists, because they considered rDNA just another tool in the tool 443

Worth, Gretchen, (1985). ÒMaking Snow While the Sun Shines: Out of the Lab and onto the Slopes.Ó Working Woman. v. (April) p. 78. 444 Ibid. 445 New York Times, Thursday, December 27, 1984, p.10. 446 Memo from Roy Lovvorn, Acting Administrator of CSRS, to Orville Bentley, the Assistant Secretary for SEA (Science and Education Administration of USDA), dated August 16, 1983. Tolin Archive. Box #1, Folder 6-2.

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box, not something unique that was deserving of special regulatory attention. A few days after a November 3, 1983 meeting between EPA and USDA, John Fulkerson also expressed anxiety over EPAÕs plan to exert control over rDNA in an internal memo to then A-RAC chairman, Ed Kendrick.4 4 8

FulkersonÕs group of CSRS administrators of research

firmly believed that oversight of rDNA, beyond that which was already in place, was unnecessary.

In the same memo, Fulkerson hinted at what

he felt was an inappropriate connection between the EPA and the Gore Report through its author, Morris Levin.4 4 9 The Fulkerson memo also drew attention to Executive Order #11987 (1977) from the Carter Administration regarding the restriction of the introduction of exotic species.

The order had given the Secretary of

Agriculture some say in allowing exemptions for those organisms found not to have an adverse effect on natural ecosystems.

The implication

was that USDA could invoke jurisdiction over rDNA against the EPA by using this authority.4 5 0 The private sector had a slightly different reaction.

Generally

speaking, industry did not want EPA to segregate biotechnology products into a separate category for regulatory purposes.4 5 1 On the other hand, industry did want a clear oversight plan, but policy planning was not keeping up with the technology. 447

Because the Rifkin

Ibid. Memo from John Fulkerson, principal scientist at CSRS, to Ed Kendrick, the Acting Assistant Secretary for USDA-SEA and chairman of the A-RAC, dated November 15, 1983. Tolin Archive, Box # 1, Folder 6-2. 449 Ibid. 450 Ibid. 451 Fishbein, Gershon W., ed., (1983). ÒBill Would Give EPA Authority over Biotechnology Products.Ó Genetic Engineering Letter. v. 3. (2) November 24. p. 1. 448

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lawsuit (FET v. Heckler - see next section) had temporarily blocked the RAC from approving release protocols, the multinational giant, Monsanto, planned to go directly to EPA for permission to test a genetically engineered pesticide.4 5 2 According to former White House staffer, John Cohrssen, the Reagan Administration feared that if the EPA were allowed to regulate rDNA, the technology might be strangled in its infancy.4 5 3 The Reagan Administration was certainly not interested in strengthening the position of regulatory agencies over business and technology development, least of all the EPA. EPA disputes with Republican administrations were not unusual. During the Nixon and Ford administrations, the Office of Management and Budget (OMB) in the Executive Office of the President Òrepeatedly denied the agencyÕs requests for funds.Ó4 5 4

Only during the Democratic

Carter Administration did Douglas M. Costle, then EPA Administrator, announce the absence of a Òhostile relationship between OMB and EPA.Ó4 5 5 452

Sun, Marjorie, (1984). ÒBiotechnology's Regulatory Tangle.Ó S c i e n c e. v. 225 (August 17) pp. 697-698. 453 Interview with John Cohrssen, J.D. former legal counsel, Cabinet Council Working Group on Biotechnology, Reagan Administration. Washington, DC (December 19, 1997). 454 Current Biography Yearbook 1980. (1981). Moritz, Charles, ed. ÒDouglas M. CostleÓ. The H.W. Wilson Company. New York. See p.56. Republican antagonism toward the EPA is not limited to the Executive Branch. The Republican Contract with America presented to the 104th Congress in 1995 included promises to curb EPA's powers, because companies were allegedly complaining that EPA was regulating them out of business. Authors of the Contract promised to force federal agencies to assess the risk and cost of imposed regulation, and singled out the example of the Clean Air Act, which they claimed the Democrats designed expressly to forbid agencies from weighing economic effects of implementing their regulations. Gillespie, Ed and Bob Schellhas, Eds. (1994). Contract With America: The Bold Plan by Rep. Newt Gingrich, Rep. Dick Armey, and the House Republicans to Change the Nation Washington, Times Books, Random House. 455 Current Biography Yearbook 1980. (1981). Moritz, Charles, ed. ÒDouglas M.

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Several of the subjects interviewed for this study furtively voiced the opinion that the White House pushed a reluctant USDA into managing the release of rDNA into the environment in order Òto prevent the EPA from regulating it.Ó

In fact, there was widespread belief at the

time that President Reagan may have appointed Anne Gorsuch (later Burford) as EPA Administrator in a calculated move to dismantle the agency.4 5 6

Anne Gorsuch-Burford was committed to President ReaganÕs

goals of reduced government spending and minimal regulatory burdens on business and industry.4 5 7

Gorsuch-Burford immediately became

controversial for her proposals on such matters as the EPA budget and regulation enforcement, which caused environmentalists and lawmakers to claim that she was destroying the effectiveness of the agency by turning it into a toothless tiger.4 5 8 Douglas M. Costle, the EPA Administrator for President Carter, was quoted as saying of GorsuchBurfordÕs budget proposals, ÒThis is a wrecking crew at work.Ó4 5 9 The appointment of Gorsuch was opposed from the beginning by environmentalists, as evidenced by their hostility at her Senate confirmation hearings on May 1, 1981.4 6 0

Only the Senate confirms

CostleÓ. The H.W. Wilson Company. New York. See p.56. 456 Davies, J. Clarence, (1984). ÒEnvironmental Institutions and the Reagan AdministrationÓ in Environmental Policy in the 1980s: Reagan's New Agenda. N. J. Vig and M. E. Kraft, Eds. Washington, DC. Congressional Quarterly Press. pp. 143160. Also, Bartlett, Robert V., (1984). ÒThe Budgetary Process and Environmental PolicyÓ in Environmental Policy in the 1980s: Reagan's New Agenda. N. J. Vig and M. E. Kraft, Eds. Washington, DC. Congressional Quarterly Press. pp. 121-141. 457 Current Biography Yearbook 1982. (1983). Moritz, Charles, ed. ÒAnne (McGill) GorsuchÓ. The H.W. Wilson Company. New York. See p. 125. 458 Ibid., p.123, 124. 459 Ibid. at p. 125. 460 Environmental Action, which would later, with Rifkin, engage in litigation against rDNA, flatly opposed the confirmation of Gorsuch, because, they said, she was Òan administrative noviceÓ with Òweak environmental credentials.Ó The Sierra Club also expressed concern that Gorsuch would be unlikely to stand up to decisions regarding EPA that would be taken by Vice President BushÕs Regulatory

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presidentially appointed cabinet officials.

170

The Republican Senate

majority, not surprisingly, confirmed President ReaganÕs selection of Anne Gorsuch as EPA Administrator, despite apprehension expressed at the hearing by Democratic Senators. For example, Senator Alan Cranston (D-CA) expressed concern that Gorsuch might have agreed to a Òhit listÓ of EPA regulations as a condition of appointment.

Senator Max Baucus

(D-MN) was worried that Gorsuch might take orders from her close personal friend, Interior Secretary James Watt, and perhaps focus on reducing regulations instead of upholding the independent mission of the EPA.4 6 1

Scandal plagued both Gorsuch-Burford and her Superfund

Director, Rita Lavelle.4 6 2

After Gorsuch-BurfordÕs forced resignation in

March of 1983, Reagan reappointed William Ruckleshaus, a noncontroversial and widely respected Washington insider who had been EPAÕs first administrator under President Nixon, to head the agency.4 6 3

Rifkin Rattles the RAC On September 14, 1983 Jeremy Rifkin, president of the Foundation on Economic Trends (FET), and his attorney, Edward Lee Rogers, filed a lawsuit on behalf of himself and Michael W. Fox, of the Humane Society Relief Task Force. U.S. Congress. Senate Committee on Environment and Public Works, (1981). Nominations of Anne M. Gorsuch and John W. Hernandez, Jr. U.S. Government Printing Office. Washington, DC. May 1 and 4. Hearing. 87-259-O. See pp.66 (Environmental Action) and p.69 (Sierra Club). 461 Ibid. See p.8 (Cranston) and p.14 (Baucus). 462 Congressional hearings by John DingellÕs Oversight and Investigations Subcommittee (House Energy and Commerce Committee) found these EPA officials too cozy with the regulated industry. Called Òsewergate,Ó the Superfund scandal resulted in LavelleÕs imprisonment and Gorsuch-BurfordÕs forced resignation. For more detail, see Greenberg, Eric J., (1993). ÒToxic Temptation :The Environmental Protection Agency's Superfund ProgramÓ. Center for Public Integrity. Accessed March 31, 1999. 463 Andrews, Richard N. L., (1984). ÒDeregulation: The Failure at EPAÓ in Environmental Policy in the 1980s: Reagan's New Agenda. N. J. Vig and M. E. Kraft, Eds. Washington, DC. Congressional Quarterly Press. pp. 161-180. See p.177.

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of the United States, Environmental Action, Inc., and the Environmental Task Force.4 6 4

Defendants named in the suit were the Secretary of

Health and Human Services, Margaret Heckler, the NIH Director, James Wyngaarden, and the Director of the National Institutes of Allergy and Infectious Diseases, Richard Krause, in his capacity as supervising director of the RAC.4 6 5 Heckler.)

(Hereafter, the case will be referred to as FET v.

Rifkin, et al., sought and won a preliminary injunction against

the RAC for approving the release of rDNA into the environment without having first prepared an environmental impact statement for such a major change in policy.4 6 6 In that September, 1983 preliminary hearing, Judge John J. Sirica (of Watergate fame), had considered it likely that Rifkin would prevail in his suit arguing that NIH had illegally approved the outdoor Ice-Minus experiment.

Therefore, Sirica enjoined the NIH from approving

experimental release of rDNA microorganisms into the environment and ruled that the preliminary injunction was to remain in effect until a

464

Michael W. Fox was Vice President of HSUS, an veterinarian and author of books on animal behavior, and a proponent of animal welfare. Environmental Action, Inc. sponsored the first Earth Day in 1970. U.S. Congress. Senate Committee on Environment and Public Works, (1981). Nominations of Anne M. Gorsuch and John W. Hernandez, Jr. U.S. Government Printing Office. Washington, DC. May 1 and 4. Hearing. 87-259-O. See p.66. 465 Foundation on Economic Trends, et al. v. Margaret Heckler, et al., U.S. District Court for the District of Columbia, Civil Action No. 83-2714, filed September 14, 1983. 22 pp. (Hereafter FET v. Heckler) For an in-depth analysis of this case see Lidsky, Michael Alan, (1986). The Potential Challenges Facing USDA in Regulating the Release of Genetically Engineered Organisms Under the Federal Plant Pest Act. Master's Thesis. National Law Center. The George Washington University. Washington, DC. Case was decided on May 16, 1984, as a partial victory for the plaintiffs. Sirica, Judge John, (1984). Foundation on Economic Trends v. Heckler. Washington, DC. May 16. Memorandum and Order. D.D.C., C.A. No. 83-2714. 466 Environmental assessments (EA) or environmental impact statements (EIS) are required on any major actions taken by federal agencies by the National Environmental Policy Act. For a discussion on RifkinÕs motivation for his actions against biotechnology, see Chapter Ten.

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final judgment was made regarding whether NIH had complied with NEPA.4 6 7

The outcome of the case, decided on May 16, 1984 eventually

gave a partial victory to Rifkin in that an environmental assessment had to be documented before Ice-Minus was released.4 6 8

(See Chapter

Eight.) According to NEPA, any agency that promulgates a major action must first consider potential effects on the environment.

Rifkin asserted that

neither the Guidelines themselves nor the actions taken under them had been supported by an environmental impact statement.4 6 9

Although the

suit alleged that the NIH had illegally approved a total of three field tests in violation of NEPA, the case focused on Ice-Minus and the possibility that the organisms used could play a role in global climatic changes, if they were swept into the upper atmosphere, because of their lack of ice-nucleating properties.4 7 0 Having received RAC approval in June 1983, Steven Lindow at U.C.Berkeley had planned to conduct the field test of Ice-Minus on a field of potatoes in Tulelake, California, during the first frost that fall.

However,

the tests were delayed again when Rifkin threatened legal action timed

467

Sirica, Judge John, (1984). Foundation on Economic Trends v. Heckler. Washington, DC. May 16. Memorandum and Order. D.D.C., C.A. No. 83-2714. Interpretation of FET v. Heckler decision is in Lidsky, Michael Alan, (1986). T h e Potential Challenges Facing USDA in Regulating the Release of Genetically Engineered Organisms Under the Federal Plant Pest Act. Master's Thesis. National Law Center. The George Washington University. Washington, DC., p.25. 468 Sirica, Judge John, (1984). Foundation on Economic Trends v. Heckler. Washington, DC. May 16. Memorandum and Order. D.D.C., C.A. No. 83-2714. 469 FET v. Heckler See p.17. 470 FET v. Heckler See pp.13, 14. Recall that NIH had also approved the corn project at Stanford University and a protocol for tomatoes and tobacco at Cornell University. (See Chapter Six.) However, neither of these projects was so close to actual field release as Ice-Minus. Also, Ice-Minus was a bacterium, not a whole plant, and as such was potentially more useful to Rifkin in invoking public concern.

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to coincide with one of the only seasonal periods when such field work was possible.4 7 1 According to a Los Angeles Times report, Rifkin had telephoned Lindow to inform him that he would seek a temporary restraining order to keep Lindow from performing his test.4 7 2 In FET v. Heckler, Rifkin et al. further lodged the complaint that there were no ecologists on the RAC, thus claiming that the RAC lacked the expertise necessary to make sound decisions on environmental release issues.4 7 3

Note that it was only one month later (October 21)

that Representative Gore pressured the RAC to appoint terrestrial ecologist, Frances Sharples.

(See Chapter Six.)

On September 16, two days after filing FET v. Heckler, RifkinÕs group also filed for a restraining order to prevent the RAC from discussing any proposals in closed session during their meeting scheduled three days later.

The first two proposals from private firms were to be presented

in executive session (closed to the public) at the September 19, 1983 RAC meeting under Òvoluntary compliance.Ó

Rifkin was opposed to RAC

review of private proposals because he did not want private corporations to benefit from biotechnology nor from any publicly funded research.

471

This time, the restraining order was denied.4 7 4

Press release from U.C. Berkeley April 6, 1984, announcing intent to conduct field test of Ice-Minus on potatoes. Tolin Archive, Box #10, Folder: Ice Nucleation. 472 Dembart, Lee, (1983). ÒThreat of Suit Delays UC Plant Biologists' Test of Los Angeles Times. Los Angeles. October 6, Genetically Engineered Organisms.Ó pp. I.3, 14. 473 FET v. Heckler See pp.16, 18. 474 Minutes of the RAC meeting, September 19, 1983, p. 10; in U.S. Department of Health and Human Services, (1986). Documents Relating to "NIH Guidelines for Research Involving Recombinant DNA Molecules" September 1982 - September 1984, Office of Recombinant DNA Activities, NIH Publication No. 86-2863. See p.194.

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On September 19, Rifkin and his co-litigants attended the RAC meeting.

Rifkin presented four demands to the RAC.

In brief, Rifkin

demanded to know the following: 1 . Why the RAC had failed to comply with NEPA, 2 . Why the RAC was evaluating release proposals with no ecologists among their membership, 3 . How the RAC could have found environmental risk to be minuscule despite the absence of any established procedures for assessing risk of rDNA, and, 4 . How the public would gain information about environmental impacts of private sector experiments if meetings were held behind closed doors.4 7 5 No doubt encouraged by his early success in SiricaÕs court, the Rifkin offensive continued.

On or about September 22, 1983 Rifkin also sent a

letter to Acting Director Richard Krause, calling for Òan immediate internal investigationÓ of the RAC and Òa full public reportÓ about alleged conflict of interest.

Rifkin charged that certain RAC membersÕ

decisions would be Òtainted by their corporate self-interests.Ó4 7 6 Rifkin was referring to RAC member Winston Brill of Cetus Madison Corporation and David Martin of Genentech.

An NIH official dismissed

the accusations, claiming that ÒthereÕs no problemÓ because corporate affiliation was allowed, so long as the member left the room when there was a vote on something relating to his or her own firm.4 7 7

475

Minutes of the RAC meeting, September 19, 1983 Attachment II in U.S. Department of Health and Human Services, (1986). Documents Relating to "NIH Guidelines for Research Involving Recombinant DNA Molecules" September 1982 September 1984, Office of Recombinant DNA Activities, NIH Publication No. 862863. See pp.212-213. 476 May, Lee, (1983). ÒConflict of Interest Seen in Approval of Tests of Gene-Altered Bacteria.Ó Los Angeles Times. Los Angeles. September 23, p. I.14. 477 Ibid., p.14.

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Rifkin was relentless.

175

On November 7, 1983, on behalf of the same

group of environmentalists who had brought the initial injunction against the NIH, Rifkin and his attorney, Edward Lee Rogers, sent proposed revisions to the NIH Guidelines for consideration at the next meeting.

Rifkin argued that if the RAC intended to approve the

deliberate release of rDNA into the environment, this orientation away from containment should be expressed in the Guidelines.

In addition,

he demanded that a programmatic environmental impact statement be prepared for the program involving deliberate release and that e a c h approved protocol should require the preparation of either an environmental impact statement or a less involved environmental assessment.4 7 8

The Talbot Boundaries Proposal The tumultuous year of 1983 drew to a close on an undoubtedly frustrated Bernard Talbot, then Deputy Director of NIH-NIAID.

Talbot

sent a memo to the Director of ORDA asking that four questions regarding the future of the RAC be issued for public comment and for consideration by the RAC at their next meeting. referred to hereafter as the Boundaries Proposal.

The document will be 479

Talbot presented

four questions, which I paraphrase here: 1 . Should the NIH Guidelines be limited to contained laboratory research? 2 . Should the RAC review only federally funded proposals? 3 . Should all portions of RAC meetings be open to the public (i.e. accept no proprietary data)?

478

(49 FR 696). The Talbot Boundaries Memo, dated December 21, 1983, from Deputy Director Bernard Talbot to William Gartland, Director of ORDA. RAC document number 1125. 479

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4 . Should the NIH Guidelines be limited to biomedical research? Talbot knew that the NIH was treading across a political minefield. The RAC had admitted a lack of expertise on agricultural and environmental issues.

The Department of Health and Human Services,

and NIH in particular, were suffering a lawsuit and steady pressure from Rifkin.

With NIHÕs limited legal staff, it would have been

impossible to comply with NEPA for potentially every rDNA release proposal.

The Congress did not want NIH overreaching its authority by

overseeing the private sector.

Moreover, the PresidentÕs Commission

report, Splicing Life, had provided a convenient alternate raison dÕ•tre for the RAC, in oversight of human gene therapy.

Could the RAC

abandon the sticky issue of environmental release of rDNA and restrict its activities to applications within its comfort zone?

In light of these

criteria, Talbot was asking whether the RAC was still the right place for evaluating rDNA issues other than federally funded biomedical research.

Responses to the Boundaries Proposal The main anxiety caused by the Boundaries Memo was the vacuum that would be created if the RAC were to discontinue oversight of release of rDNA into the environment. be filled by the enthusiastic EPA.

That void would be most readily

Not surprisingly, public comments,

primarily from industry, overwhelmingly opposed TalbotÕs suggestions that the RACÕs responsibility be limited to federally funded medical research under containment conditions.

The American Society for

Microbiology joined the industry in urging the RAC to continue its role

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in oversight of rDNA activities, in both the public and private sectors, whether indoors or out.4 8 0 The advantages to industry of the continuance of the RAC in the oversight of rDNA were obvious.

Not only would it provide some degree

of legal protection to private firms to have the NIH stamp of approval, but oversight by the well-respected RAC might forestall the involvement of the more expensive approaches that were typical of the EPA. The response from the USDA to TalbotÕs questions was quite simple: ÒNoÓ to each.

There was little elaboration, except to say that there was

Òno other mechanism in place to conduct such reviews.Ó4 8 1 The advantage to the USDA, aside from not having to scavenge additional resources for the A-RAC to evaluate a growing number of proposals, would be to avoid the potential conflict of interest inherent in an agency that has promotional, research, and regulatory functions.

Furthermore,

the A-RAC was committed to the process of helping the RAC to deregulate many previously prohibited experiments.

If they could just

endure a little longer, perhaps the regulation of commercial release of rDNA would become moot.

Although there was not a unanimous show

of confidence at the January 24, 1984 A-RAC meeting that USDA could avoid regulating rDNA permanently, it seemed that the status quo was acceptable to most who were present at the meeting.4 8 2

480

Comment letters for Talbot Boundaries Memo, in Tolin Archive, Box # 1, Folder 1-4. 481 Comment letter dated February 6, 1984 from Ed Kendrick, chairman of A-RAC and Sue Tolin, USDA liaison representative to the RAC, to Bernard Talbot regarding the Boundaries Memo. Tolin Archive, Box # 1, Folder 1-4. 482 Minutes of the A-RAC meeting, January 24, 1984, p.2. Tolin Archive, Box #1, Folder: 6-3.

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Again, the EPA was the only federal agency which appeared eager to take over rDNA release issues so the NIH could focus on biomedical research.

However, a response letter from Don Clay, EPAÕs Director of

the Office of Toxic Substances, urged the RAC to continue Òuntil a clear delineation of responsibilities [for other agencies] can be developed.Ó4 8 3 The EPA was no doubt still recovering from deep budget cuts and the recent scandal which resulted in the removal of its Administrator, Anne Gorsuch-Burford. Except for the EPA, only Committee for Responsible Genetics (CRG) members Susan Wright and Philip Bereano responded with anything other than flat rejection of the Boundaries proposal.

Both Wright and

Bereano complained about having received the Federal Register notices too late to prepare meaningful responses. 4 8 4 do it if not the RAC?

Wright asked who would

It is not clear how Bereano would have responded,

because his letter focused on not having been given enough time to respond.4 8 5

A second letter from Bereano, three months later regarding

the solicitation of public comments on the Gore Report, also complained bitterly about the lack of time that had been allowed for public review and comment.

483

He wrote,

Comment letter from Don Clay, EPA, for Talbot Boundaries Memo, in Tolin Archive, Box # 1, Folder 1-4. Although Clay promised that EPA supported the development of a regulatory framework that would require interagency coordination, he also admitted that EPA was not ready to assume its full responsibilities. 484 Apparently, by the time potential respondents other than Capitol Beltway insiders received and read the Federal Register notice, only one week remained of the 30 day comment period. 485 Letters to James B. Wyngaarden reprinted in U.S. Department of Health and Human Services, (1986). Documents Relating to "NIH Guidelines for Research Involving Recombinant DNA Molecules" September 1982 - September 1984, Office of Recombinant DNA Activities, NIH Publication No. 86-2863. from Susan Wright, p.628; from Philip Bereano, pp. 664.

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ÒIt is impossible to provide meaningful comment and contribute to a rational decision process when ORDA affords so little time for participation to interested and knowledgeable persons on its mailing list.Ó4 8 6 I am convinced that BereanoÕs expression of anger at a system which made him feel excluded from the rDNA decision making process is an underappreciated, extremely important symptom of an unsatisfied need.

As I pointed out earlier, a place at the table enables those who

feel they will be affected by decisions to have the opportunity to prevent the shaping of a policy that would have affected them negatively.

Agricultural scientists had received that opportunity.

Critics of the technology still felt excluded.

It was important then, it

continues to be important today, and perhaps will always be more important to some than any number of discussions about safety, that they be consulted for their opinions and permissions before public decisions are made.

The Twilight of a Paradigm The year 1983 saw a staking out of positions on biotechnology, and, not surprisingly for Washington, a polarization of views along what approximated political perspectives.

There were, for example,

conservatives in the Administration who wanted to retain the privileges of academic and entrepreneurial freedom for the sake of economic advancement.

There were also liberals in the House of Representatives

who wanted to preserve the freedoms of information and choice, as well 486

Letter from Philip L. Bereano to William Gartland, reprinted in U.S. Department of Health and Human Services, (1986). Documents Relating to "NIH Guidelines for Research Involving Recombinant DNA Molecules" September 1982 - September

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as radicals on the outside of the dominant institutional structures who would make the most use of every foible or failure of the technology to agitate for social reform.4 8 7 By the end of 1983, the international Organisation for Economic Cooperation and Development (OECD) had begun to show significant interest in biotechnology.

There had already been a meeting of the

OECD ad hoc committee on Safety and Regulations in Biotechnology in Paris, France on December 6 and 7, 1983.

Although no consensus could

be reached even on basic definitions involving rDNA, many delegates present at the OECD meeting indicated that they used U.S. NIH Guidelines or a variation on NIH Guidelines as the basis for oversight in their own countries.4 8 8

The OECD was waiting for position papers from

the U.S., which had been designated as the lead country in the study of release into the environment, before proceeding further.4 8 9 Clearly, whatever the RAC decided to do would impact the international scene and would be of great economic importance to the U.S. In early 1984, a somewhat reluctant RAC was still the only federal instrument for biotechnology oversight.

The Reagan Administration and

proponents of rDNA had a powerful incentive to see that regulation of biotechnology world-wide did not inhibit U.S. competitiveness in the new field.

On the other hand, leading Democrats from the source of

NIHÕs bread and butter, the U.S. House of Representatives, were insisting that oversight of private firms was necessary, but that the RAC had no 1984, Office of Recombinant DNA Activities, NIH Publication No. 86-2863. p. 682. 487 At this point I am using Ôconservative,Õ Ôliberal,Õ and ÔradicalÕ in a general way. See my final chapter for an expansion of these concepts. 488 Unclassified Telegram from American Embassy in Paris to Secretary of State in Washington, DC, dated December 9, 1983. Tolin Archive, Box #1, Folder: 6-2. For more information on OECD see also .

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legal authority to regulate.

181

Caught in the middle, between a

conservative administration that wanted no new regulations and a liberal Congressional caucus that wanted a more cautious approach to rDNA that was responsive to the demands of environmentalism, the RAC pondered its dilemma.

Elizabeth Milewski recounted the RACÕs

predicament: ÒThe issue was how to keep some level of preeminence so their opinions would be valued, but at the same time not be tarred with the idea that they had become a regulatory agency with all of the problems that being a regulatory agency entails.4 9 0

Summary The old paradigm of containment and single-agency oversight of rDNA was rapidly unraveling.

The RAC lacked the authority and the

enthusiasm to oversee the release of rDNA into the environment. Proposal submissions to the RAC for permission to release rDNA into the environment would increase in number and the publicÕs unanswered questions about social effects of the technology would begin to pile up. Bernard Talbot of the NIH had formally suggested that the RAC abandon the release issue and private sector altogether and oversee rDNA within the boundaries of federally funded biomedical research only.

But the

RAC was the de facto regulatory body for all rDNA work; Who would take over for the RAC if it were to stop serving this function?

489

Ibid. Interview with Elizabeth Milewski, Ph.D. formerly on staff at NIH-ORDA, presently Special Assistant for Biotechnology, EPA. Washington, DC (December 5, 1997). 490

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Critics and proponents alike had dug in their heels for an inevitable conflict when the political cycle for rDNA policy reached a threshold4 9 1 Because the participants were essentially the same ones in as in the Containment Era, the new issues of the Release Era only provided new arenas in which to clash.

At least one high ranking member of the

agricultural community was of the opinion that RifkinÕs lawsuit was responsible for stimulating a jurisdictional battle among federal regulatory agencies.4 9 2

The Release Era had moved quickly from

polarization into the period of conflict. On the regulatory side of USDA, APHIS began to examine regulatory possibilities, despite the protest of their colleagues in perfecting its Òwait and seeÓ strategy.

CSRS, which was

The EPA, with the direct

encouragement of several ranking House Democrats, began to assert its right to regulate rDNA research by stretching the limits of its TSCA and FIFRA statutes, although it did not have the resources to regulate rDNA adequately.

The Congress did not want the RAC acting as a regulatory

body because it did not have legislative authority to do so.4 9 3 The Reagan Administration began to worry that the Congress might succeed 491

The concept of technology controversy imbedded in a political cycle is explored by Jasper, James M., (1988). ÒThe Political Life Cycle of Technological Controversies.Ó Social Forces. v. 67 (2) (December) pp. 357-377. 492 Charles Hess so testified before the Assembly Committee on Economic Development and New Technologies. Hess was then Dean of Agriculture and Environmental Sciences at the University of California, Davis, also Vice Chair of the National Science Board of the NSF, and a member of the Committee on Biotechnology of NASULGC. Hess testimony, Assembly Committee on Economic Development and New Technologies, San Francisco, California, June 28, 1984 Tolin Archive, Box #1, Folder: 6-4. 493 In fact, one of the RAC members, A. Karim Ahmed, had withdrawn himself from all closed sessions of the RAC in protest of the RACÕs Òacting in a ÔquasiregulatoryÕ manner when they are required to respond to proprietary proposals.Ó Ahmed, A Karim, (1984). ÒLetters: ÔRecombinant DNA CommitteeÕ.Ó S c i e n c e. v. 223 (February 3) p. 440. Ahmed was a research director with the Natural Resources Defense Council, Inc.

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in channeling all oversight for release of rDNA to the EPA.

183 Meanwhile,

Jeremy Rifkin was waging one offensive after another to frustrate anyone who would attempt to authorize environmental release experimentation with rDNA. The USDA continued to urge the RAC to revise the Guidelines to allow for testing of rDNA organisms outdoors.

The White House was

encouraging APHIS to take over rDNA regulation before the EPA could do it.

Simultaneously, the Congress, the EPA, and public interest groups

were trying to slow the rapid evolution of rDNA policy relaxation.

The

antagonism took place on many levels; between the Administration and the House of Representatives, between the EPA and other Executive Departments, and between agencies within one Department (USDA). Added to the equation was the embarrassment suffered by the U.S. as the international community beheld the brouhaha. By 1984, the controversy had become so complicated, so widespread, and so widely publicized that it would be impossible to examine here all of the events at the same level of detail as I have employed up to now. The literature is already rich in examples of confrontation during the mid-1980s.

For that reason, I have chosen to emphasize some aspects

of the controversy over others. The vignettes I have selected to acknowledge in Part III of this work were chosen to enable me to focus on the perspectives of three key perspectives on the rDNA release issue while maintaining a chronological flow of events.

Incidents were also chosen based on

availability of complete and reliable information, on the extent to which they illustrate the many levels at which controversy existed, and on their relative influence on the political correction of agricultural

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184

I will leave to others, or to my own future work, the

documentation of the many safety and ethical arguments and focus here instead on the underlying philosophies of those who attempted to influence the path of biotechnology regulation. In the next chapter I will focus on the turmoil within the USDA as it was dragged toward regulation of rDNA.

PART III - WHO WILL CONTROL THE GENIE?

ÒIn Washington, whenever anything is significant, there are always turf battles. ... Face it!

TheyÕre turf battles.4 9 4

- Terry L. Medley, Former Administrator, APHIS, USDA. ÒThe EPA and USDA regulations for field testing genetically engineered microorganisms are massive, confusing, and overlapping. The technology is being regulated into submission.4 9 5 - Winston Brill, Vice President, Agracetus ÒThere are few more reliable ways of being expelled from a culture than continuing seriously to query its taken-for-granted intellectual f r a m e w o r k .4 9 6 - Shapin and Schaffer (1985) Leviathan and the Air Pump. ÒSociety does not fear science ... so much as it fears greed.4 9 7 - Len Richardson, Editor, California

494

Farmer

Interview with Terry L. Medley, J.D. former Director of USDA-BBEP and Administrator of APHIS, USDA. Washington, DC (December 11, 1997). 495 Brill, Winston J., (1988). ÒWhy Engineered Organisms are Safe.Ó Issues in Science and Technology. v. (Spring) pp. 44-50. See p.46. 496 Shapin, Steven and Simon Schaffer, (1985). Leviathan and the Air Pump: Hobbes, Boyle, and the Experimental Life. Princeton, NJ, Princeton University Press. 497 Len Richardson, an editor of several agricultural trade journals, is reported to have suggested this at a Keystone Meeting. Keystone Center and Environmental Citizen State and Local Leadership Initiative for Biotechnology, (1989). ÒWorkshop SummaryÓ. Conference: West Coast Regional Workshop, Tiburon, CA, The Keystone Center. See p.11.

CHAPTER EIGHT: 1984 - A HOUSE DIVIDED Introduction Early in 1984, the Agriculture rDNA Advisory Committee (A-RAC) faced a full schedule.

It was preparing to respond to the

recommendations of the anticipated Gore Report, keeping track of Jeremy RifkinÕs complaints, and advising the RAC by reviewing protocols on request and by providing information to RAC working groups that were revising the Guidelines to facilitate agricultural research.

The A-RAC, established in the USDA research division and led

by CSRS, continued to support the RACÕs status as the only federal agency officially involved in the oversight of the rDNA research, which included the release issue. Before long, another voice was heard--from the regulatory side of USDA.

The Animal and Plant Health Inspection Service (APHIS),

previously in the background except for representation and participation at A-RAC meetings, had determined that the EPA was about to step on its jurisdictional toes.

In order to stave off EPA

regulation of agricultural products, APHIS began to offer its own policy convictions about rDNA.

Unfortunately, the sudden interest by APHIS

in regulating rDNA appeared to those on the research side of USDA to be counterproductive.

Because there were no agricultural rDNA products

yet, premature interest by APHIS was interpreted as a desire to regulate agricultural r e s e a r c h, and a trespass on the domain of CSRS. Opinions varied on how best to approach the regulation question-especially where research was concerned.

These philosophical

differences engendered a disturbance to the internal equanimity of the

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department that would ebb and flow for several years.

As a result,

USDA appeared, to the outside world, to be a house divided regarding regulation of rDNA release. 4 9 8 This chapter in particular illustrates the multi-level periodicity that existed in the rDNA controversy.

It describes some of the activities of

the A-RAC during the critical year of 1984 and the pressure it received from both inside and outside the department to come forward with a plan to regulate release of rDNA--including releases purely for research. I will focus on the genesis and growth of tension and alienation among research and regulatory agencies within USDA, as documented primarily in records of the A-RAC and written communications among its members.

I will also refer to relevant concurrent events in other

sectors that formed the context in which the drama unfolded.

(A partial

1984 USDA organizational chart is provided in Appendix J to illustrate diagramatically the relationships among the agencies mentioned in this chapter.)

Gestation: ÒGuidelines OnlyÓ Viewpoint Falters - Winter 1984 Several members present at the January 24, 1984 A-RAC meeting were dismayed by the EPA expression of intent, on November 8, 1983, to exert regulatory control over experimental release of rDNA into the environment under its FIFRA and TSCA statutes.

Recall from Chapter

Seven that at that November meeting, EPA announced to USDA its decision to classify Ice-Minus as a pesticide.4 9 9 498

Several A-RAC members

U.S. General Accounting Office, (1986). Biotechnology: Agriculture's Regulatory System Needs Clarification. GAO. Washington, DC. March. Report to the House Committee on Science and Technology. GAO/RCED-86-59., p.2-3 499 Minutes of A-RAC meeting, November 8, 1983. Tolin Archive, Box #1, Folder: 62.

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worried that the EPA plan would potentially create Òa bureaucratic nightmare for scientists and industries alike.Ó5 0 0 Another concern, especially for the agricultural research community, stemmed from the recent interest that Marketing and Inspection Services, the division of USDA that includes APHIS (regulatory side), had begun to show in playing a larger role in rDNA oversight.

This

point requires some background on a concurrent activity initiated by the EPA, which spearheaded a rift between the research and regulatory divisions at USDA. In September of 1983, the new EPA Administrator, William Ruckleshaus, had proposed the formation of a risk management group of principals for coordination of overlapping efforts in the regulation of rDNA.5 0 1

This group became the Interagency Risk Management Council

(IRMC) and was led by the EPA.5 0 2

The group included high ranking

officials from the Consumer Product Safety Commission, the Food and Drug Administration (FDA), USDA Marketing and Inspection Service, and the Occupational Safety and Health Administration (Department of Labor).5 0 3 500

The strategy was for the IRMC Òto Ôidentify potential

Minutes of the A-RAC meeting, January 24, 1984, p.1. Tolin Archive, Box #1, Folder: 6-3. Members expressing this opinion were not named in the minutes. 501 Letter from William D. Ruckelshaus, EPA, to John R. Block, Secretary of Agriculture, dated September 21, 1983. Tolin Archive, Box #1, Folder: 6-2. ÒPrincipalsÓ in this case is a term used to mean high ranking, usually presidentially appointed, officials for the specified agencies. Most actual work is done by assistants and consultants, but final decisions and responsibility lie with the principals. 502 The IRMC, established in fall, 1983, was not the same as the federal interagency group that was created by order of President Gerald Ford in 1976. The latter group had gone dormant once Reagan took over. There were many committees formed and dissolved during this period by many different groups that had an interest in biotechnology. Often the same people would appear on multiple committees, or incarnations of committees, both within and between agencies. 503 Uncited author, (1984). ÒIRMC Puts Off Plan on Biotechnology.Ó Inside EPA (Weekly Report). Washington, DC. March 30, pp. 10-12.

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regulatory gapsÕ and avoid Ôoverlapping jurisdictionÕ as well as assure consistency in the way agencies regulate[d].Ó5 0 4

However, although no

reason was specified, the IRMC had decided Òby tacit agreementÓ to exclude from membership in the group the White House Office of Management and Budget (OMB), despite OMBÕs expressed interest in biotechnology.5 0 5 At a late March, 1984 meeting of the IRMC, EPA had hoped to bid for the lead in the policy coordinating effort for rDNA risk management, but a counter proposal by the excluded OMB to form a competing group caused the suspension of workplans.5 0 6

That same month, it was

reported by Inside EPA that OMB had proposed the establishment of a working group of the Cabinet Council on Economic Affairs for the purpose of examining the need for regulatory authority for biotechnology.5 0 7

The proposal, written by OMBÕs chief of regulatory

affairs, Christopher DeMuth, Òdirectly challenge[d] EPAÕs announced intention to regulate biotechnology products under the Toxic Substances Control Act [TSCA].Ó5 0 8

As an alternative, it was suggested by DeMuth

that the Cabinet Council establish a Working Group on Biotechnology. Naturally, DeMuth believed that the working group could more favorably be chaired by the White House OMB, n o t the EPA. It was rumored that the formation of the IRMC itself may have been a calculated move by the EPA to anticipate the soon-to-be-released Gore 504

Ibid., p.11. Ibid., p.11. The OMB oversees the Federal budget, evaluates policies of federal agencies, and ensures consistency with the AdministrationÕs goals. 506 Uncited author, (1984). ÒIRMC Puts Off Plan on Biotechnology.Ó Inside EPA (Weekly Report). Washington, DC. March 30, pp. 10-12. See p.11. 507 Uncited author, (1984). ÒOMB Challenges EPA Plan to Regulate Biotechnology in Cabinet-level Draft.Ó Inside EPA (Weekly Report). Washington, DC. March 30, p. 1+10., p.1. 505

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ReportÕs recommendation for such a body.5 0 9

190

The establishment of the

Cabinet Council Working Group on Biotechnology appears to be one of many preemptive moves by the Reagan White House to prevent the EPA from securing leadership status in rDNA affairs.

Soon, the White

House would insist on USDA participation, by pressing into service the regulatory components of the DepartmentÕs Marketing and Inspection Division. Questioning the USDA Position on Regulation

Some members present at the January 24, 1984 A-RAC meeting were concerned about USDA Marketing and Inspection involvement with the competing working groups mentioned above.

Karen Darling, Deputy

Assistant Secretary of Marketing and Inspection pressed for USDA to take a leading role in the IRMCÕs Biotechnology Working Group.

Darling

had requested that USDA quickly develop a position paper similar to one prepared by EPA for presentation at the next IRMC working group meeting. A-RACÕs hesitation to prepare an overall statement for the Department was perhaps in part due to its having regulatory, research, and promotional (support of research through funding) components within USDA.5 1 0 508

It would certainly have appeared to be a conflict of

Ibid. Minutes of the A-RAC meeting, January 24, 1984, draft edition, p.2. Tolin Archive, Box #1, Folder: 6-3. Recall that a strong link existed between the Gore Subcommittee and the EPA in Gore Report author, Morris Levin. Recall also that the Gore Report would recommend that the EPA initiate the organization of an interagency panel. 510 For example, USDA performed in-house research through the Agricultural Research Service (ARS). CSRS had primarily a research coordination function for Land Grant University researchers through administration of formula funds and competitive grants. APHIS was responsible for protecting American agriculture through regulatory efforts, and relied upon ARS for research to support 509

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interest if the USDA were to regulate the research that it supported through grants, or if the USDA were to regulate the products of its own research, while funding that research and promoting the products as well.

Even though it appeared that EPA was about to encroach upon

APHIS jurisdiction, some members of A-RAC felt that it was best for USDA not to get involved with regulation of commercial agriculture rDNA applications Òsince that would be looked upon as self-serving.Ó5 1 1 The greatest disagreement was over regulation, not of commercial agricultural products (there were none yet), but of agricultural research. Members of the research community believed that the risks of introducing rDNA-containing organisms into the environment for research purposes did not warrant more oversight than was provided by the NIH Guidelines.

For example, according to plant pathologists, Sue

Tolin and Anne Vidaver, members of their discipline had routinely worked outdoors with living plant pathogens that had recognized risks and thus were more hazardous than the perceived risks associated with rDNA organisms.

Plant pathologists had developed a great deal of

knowledge regarding the environmental dynamics of plant diseasecausing microorganisms.

Many of these environmental characteristics

were the very parameters (for example, survival rates, dissemination, gene transfer capability) that were causing concern among critics of rDNA, yet most of this knowledge was not brought forth in the debate.5 1 2

regulatory decisions. 511 Minutes of the A-RAC meeting, January 24, 1984 See p.1. Tolin Archive, Box #1, Folder: 6-3. This opinion was offered by S.L. Krugman (Forest Service). Bruce Cone (Deputy Assistant Secretary of Science and Education) concurred. 512 Tolin, Sue A. and Anne K. Vidaver, (1989). ÒGuidelines and Regulations for Research with Genetically Modified Organisms: A View From Academe.Ó A n n u a l

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On the other hand, the pro-regulatory position held that only by assuring the public that rDNA would be used safely--through regulation--could the development of an essential technology be ensured.

After all, rDNA technology was once considered potentially so

hazardous that it had suffered a researchersÕ self-imposed moratorium. This alternative view, based primarily not on scientific experience, but on experience with public policy, is explained by Terry L. Medley.5 1 3 ÒI was looking at regulations in a different way. Most people view regulations as additional requirements and barriers. To me, those are bad regulations. Good regulations clarify and remove uncertainty. They put up standards and assure the general public that safety is being met. They also allow for researchers and for industry to develop long range plans, because then [they] know what is going to be required.5 1 4 By the end of the January 24 A-RAC meeting, not only did some ARAC members prefer to wait for the Gore Report to be issued in February, 1984 before taking any initiative, but they were clearly anxious to Òslow downÓ Deputy DarlingÕs enthusiasm for USDAÕs proactiveness regarding rDNA regulation.5 1 5

It would seem that they

succeeded, because notes regarding a later A-RAC meeting indicated that EPA had taken over the risk management task force that Darling clearly wanted USDA to lead.5 1 6

Review Phytopathology. v. 27 pp. 551-81. See p.570. 513 Medley would later become the first Director of the former APHIS Biotechnology, Biologics, and Environmental Protection staff (1989) and Administrator of APHIS, USDA (1997 - 1998). He also represented USDA on the international biotechnology scene from 1993 - 1997. 514 Ibid. Interview with Terry L. Medley, J.D. former Director of USDA-BBEP and Administrator of APHIS, USDA. Washington, DC (December 11, 1997). 515 Minutes of A-RAC meeting, January 24, 1984, draft edition, p.2. Also handwritten notes taken at same meeting. Tolin Archive, Box #1, Folder: 6-3. 516 Handwritten note from Sue Tolin to Ed Kendrick regarding proceedings at the

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On January 31, 1984 Gerald Still, A-RAC member from the Agricultural Research Service (ARS--the in-house research division of USDA) sent a memo to Ed Kendrick, the Chairman of the A-RAC, expressing a change of heart about regulation of commercial release of rDNA.

Previously opposed to EPA regulation, Still had attached a recent

article from BIO/Technology which pointed out the advantages of EPA regulation over two extreme alternatives; doing nothing or regulating to the hilt.

The article to which Still referred presented the argument that

regulating rDNA release under TSCA would be good for industry, despite higher costs and delays, because it would assure the public that rDNA products are not so dangerous that they should be regulated any differently from other chemical products.5 1 7

Still, who also made a point

of stating that science is Òonly a partÓ of policy making, recommended using biotechnology as a means to Òstrengthen those regulatory institutions so that in the future the societal benefit is great, while at the same time society is protected.Ó5 1 8

I find StillÕs reference to Òsocial

decision makingÓ especially interesting because it employs liberal environmental rhetoric, yet it comes from a researcher associated with a very conservative institution. It must have been a blow to academic researchers being represented by CSRS for a research administrator from ARS to express a preference for a stronger regulatory approach, even though Still may have tried to soften the impact by adding his feeling that research plots of less than ten acres should not be regulated.

A later document regarding

March 20, 1984 A-RAC meeting. Tolin Archive, Box #1, Folder: 6-3. 517 Edwards, Christopher G., (1983). ÒIndustry May Benefit From EPA Regulations (editorial).Ó B I O / T e c h n o l o g y. v. (November) p. 725. 518 Memo from Gerald G. Still, USDA-ARS representative to the A-RAC, to Ed

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proceedings at an A-RAC meeting on March 20, 1984 indicated that Still wanted research covered by a piece of proposed legislation that was being prepared by APHIS (discussed below). The ten-acre limit concept was significant to A-RAC because EPAÕs statutes allowed exemptions for chemical testing for research purposes on plots of less than ten acres.

If there were problems with new

chemicals, such small sites could easily be cleaned.

However, because

living rDNA organisms might escape beyond a ten acre release site, EPA wanted to revoke the research plot exemption in the case of living rDNA organisms.5 1 9

CSRS in particular was very concerned that experimental

plots of less than ten acres should be exempted from prohibitively expensive compliance with regulations so the Land Grant University researchers, who were already constrained by limited budgets, could conduct investigations. The Gore Report was released in February, 1984.

At the A-RAC

meeting on February 21, Stanley L. Krugman, Director of Timber Management Research, U.S. Forest Service, proposed that A-RAC respond to the Gore Report with a restated overall policy of USDA regarding rDNA regulation.5 2 0

Some members pressured to postpone

yet again any effort to respond to the Gore Committee, preferring to wait and see what EPA would do.

However, APHIS came to the meeting

prepared with a proactive proposal. Robert Kahn, Senior Staff Officer of Biological Assessment Support Staff, and one of APHISÕ representatives to A-RAC, distributed a draft of Kendrick, the Chairman of the A-RAC. Tolin Archive, Box #1, Folder: 6-3. 519 Handwritten note from Sue Tolin to Ed Kendrick regarding proceedings at the March 20, 1984 A-RAC meeting. Tolin Archive, Box #1, Folder: 6-3. 520 Minutes of A-RAC meeting, February 21, 1984. Tolin Archive, Box #1, Folder: 6-

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proposed legislation entitled ÒBiological Organisms and Plant Stress Act of 1984,Ó (also called the ÒSpano BillÓ).5 2 1

The bill would have allowed

the USDA jurisdiction over any rDNA product not specifically under EPAÕs or any other agencyÕs jurisdiction.

The bill would have required,

with some exemptions, any release of rDNA to have a permit from the Secretary of USDA. For now, the chances were diminishing that CSRS scientists, led by Chief Scientist, John Fulkerson, could hold the line on their collective opinion that voluntary compliance with the NIH Guidelines constituted sufficient oversight for release of rDNA organisms, especially once they started losing unified support within their own department.

With the

prospect of losing the ten-acre exemption should EPA have its way, CSRS had to worry about the possibility that nationwide academic research, including that funded by other agencies such as NSF or the Department of Energy, might be in jeopardy. Meanwhile, at the NIH, with wholehearted A-RAC support, the RAC had established the Working Group for Release into the Environment. (See membership list in Appendix E.)

It was no surprise that the

Working GroupÕs responses to the seven recommendations of the Gore Report leaned heavily in favor of RAC control over all rDNA releases, and that they Òcompletely rejectedÓ the idea that RAC should cease

3. 521

The ÒSpano Bill,Ó named after its author Ellen Spano, a Regulatory Coordination Specialist from APHIS, was drafted and redrafted throughout the spring of 1984, but it apparently died a quiet death without ever being introduced in the U.S. Congress. Two drafts of the bill, dated February 23, 1984, and March 21, 1984, are in Tolin Archive, Box #1, Folder: 6-3.

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evaluating and approving private sector proposals.5 2 2

196 (The seven

recommendations of the Gore Report are reproduced in Appendix D.)

Threshold: Release Issue Reality Check - Spring 1984 A-RAC Faces ÒThe Big PictureÓ

At the May 1 A-RAC meeting, minutes again documented concern expressed by APHIS representatives about EPAÕs continuing activities in the rDNA arena, which were allegedly, Òcreating much confusion and anxiety among biotechnology industries.Ó5 2 3

It was suggested that

APHIS should get involved in order to circumvent EPAÕs Òcumbersome regulation of genetically engineered products [that might] drive biotechnology industries out of the U.S.).Ó5 2 4

It was also suggested that

rDNA regulation could be handled adequately using existing authorities.5 2 5 One handwritten note jotted during the May 1 A-RAC meeting indicated that Assistant Secretary for Marketing and Inspection, C.W. McMillan (regulatory division), had sent the message, ÒYou donÕt understand the big picture.Ó5 2 6

Although the context of this brief

notation was not clear, it appears to have been expressed in admonition of the A-RACÕs continued lack of support for USDAÕs potential role in rDNA regulation.

By Spring, 1984 there was much more than the EPAÕs

tip-toeing into the lead in the Interagency Risk Management Council to

522

ÒMotion by Dr. Gottesman,Ó RAC document #1151, April 9, 1984, (NIHORDA).Release Working Group notes. Tolin Archive, Box #1, Folder: 9-1. 523 Minutes of the A-RAC meeting, May 1, 1984, p.1. Tolin Archive, Box #1, Folder: 6-4. Drs. George Shibley and Robert Kahn expressed concern about EPA activities. 524 Ibid. 525 Daniel D. Jones, from the Food Safety Inspection Service, also in the regulatory division of the department, made this suggestion. Ibid. 526 Handwritten notes taken by Sue Tolin during A-RAC meeting of May 1, 1984.

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be cause for concern.

197

In March, the Reagan Administration had exerted

its leadership by establishing a White House Cabinet Council Working Group on Biotechnology to complete with EPAÕs Interagency Risk Management Council.

The Working Group would begin the coordination

of federal regulatory policy for biotechnology.5 2 7 McMillan was a member of that Working Group.

By the March 20, 1984 A-RAC meeting

it was clear that McMillan wanted USDA to Òfill the gapÓ in rDNA oversight--at least for commercial purposes.5 2 8

Immediately following

the May 9 meeting of the Cabinet Council, McMillan had sent a memo to his regulatory administrators (including APHIS) asking for a full list of existing laws, regulations, and court rulings that might apply to biotechnology.5 2 9 No doubt the White House had specifically encouraged some interagency turf grappling in order to scuttle the EPAÕs lead.

Once the

Administration had become enmeshed in the trend toward regulation, it chose to encourage the USDA to regulate rDNA release. parlance, ÒencouragementÓ generally equates to Òorders.Ó his orders.

In political McMillan had

Despite the agricultural research communityÕs unwillingness

to regulate rDNA, the White House was afraid if USDA didnÕt do it, EPA would.

Former Reagan White House staffer, John Cohrssen recalled,

ÒThe White House supported some competition among the agencies in how to regulate, because they thought 527

The development of the AdministrationÕs Coordinated Framework for Regulation of Biotechnology deserves separate attention and will be presented in Chapter 9. 528 Handwritten A-RAC meeting notes dated March 20, 1984. Tolin Archive, Box #1, Folder: 6-3. See also attachment to those minutes entitled ÒBriefing Paper, Agriculture and Recombinant DNA TechnologyÓ dated March 16, 1984, submitted by APHIS. 529 Memo from C.W. McMillan to regulatory administrators of APHIS, FSIS, and FGIS, dated May 10, 1984. Tolin Archive, Box #1, Folder: 6-4.

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that the USDA approach would be less onerous and more flexible for the new technology than either [of EPAÕs statutes] TSCA or FIFRA.5 3 0

FET v. Heckler Decided - May 19845 3 1

Jeremy Rifkin, President of the Foundation on Economic Trends, had threatened U.C.-Berkeley with an injunction against the Ice-Minus release experiment in the fall of 1983, which effectively canceled the test until spring.

Not one to hibernate, Rifkin worked throughout the

winter, collecting more testimony from scientists who were skeptical about the safety of releasing altered organisms.

The NIH legal staff also

prepared a list of scientists willing to give testimony.5 3 2 When U.C.Berkeley tried to go ahead with the test in spring, 1984, Rifkin filed for injunction. Rifkin had also filed for a temporary restraining order to halt the RAC meeting of February 6, 1984.

A January 5, 1984 Federal Register

notice announced that AGS, the biotechnology company that had partially funded LindowÕs Ice-Minus research, had submitted a request to do their own field test of the microbe.5 3 3

Because AGS was a private

firm with confidential business information at stake, part of the RAC meeting was to be held behind closed doors. 530

Rifkin objected.

His

Interview with John Cohrssen, J.D. former legal counsel, Cabinet Council Working Group on Biotechnology, Reagan Administration. Washington, DC (December 19, 1997). 531 FET v. Heckler, U.S. District Court for the District of Columbia, Civil Action No. 83-2714, filed September 14, 1983. 22 pp. This case was introduced in Chapter Seven. 532 Maranto, Gina, (1984). ÒAttack on the Gene Splicers.Ó D i s c o v e r. v. (August) pp. 19-25. See p.22. 533 (49 FR 696). January 5, 1984. National Institutes of Health. (1984). ÒRecombinant DNA Research; Proposed Actions Under Guidelines.Ó F e d e r a l R e g i s t e r v. 49: 696-700. January 5.

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motion to stop the meeting was denied by Judge Sirica on the day of filing, February 3, 1984.5 3 4

Although Sirica had denied the restraining

order, the Court of Appeals for the District of Columbia reversed SiricaÕs decision and forced the RAC to await the outcome of FET v. Heckler several months later.5 3 5 On May 16, 1984 FET v. Heckler regarding Ice-Minus was decided. Judge Sirica Òrepeatedly rebuffed attempts by attorneys on either side to present testimony from the scientific expertsÓ5 3 6 and based his decision strictly on legal technicalities involving the National Environmental Policy Act (NEPA), not on scientific evidence of hazard.5 3 7 In a case where every expert was matched with an equal and opposite expert, SiricaÕs wisdom in dissecting the legal from the scientific was Solomonic. again.

Nevertheless, progress for LindowÕs Ice-Minus was halted

ÒWe were stunned,Ó said Deputy Director Bernard Talbot of the

National Institute of Allergy and Infectious Diseases.5 3 8 prevailed.

Rifkin had

Eventually, however, both sides claimed victory because the

field test was eventually allowed to proceed, but NIH had to prepare the environmental assessments first. Barely two weeks later, the RAC approved the request from AGS to field test the same Ice-Minus organism.

Only experiments at

institutions supported by federal grants for rDNA research were affected by Sirica's injunction. 534

Rifkin had successfully foiled Lindow

FET v. Heckler. Civil Action no. 83-2714, U.S. District Court for the District of Columbia. filed September 14, 1983. 22 pp. 535 See RAC minutes of February 6, 1984, p.25. 536 Maranto, Gina, (1984). ÒAttack on the Gene Splicers.Ó D i s c o v e r. v. (August) pp. 19-25. See p.24. 537 Sirica, Judge John, (1984). Foundation on Economic Trends v. Heckler. Washington, DC. May 16. Memorandum and Order. D.D.C., C.A. No. 83-2714.. 538 Maranto, Gina, (1984). ÒAttack on the Gene Splicers.Ó D i s c o v e r. v. (August) pp.

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and the federally funded University of California. against a private firm?

200 Could he do the same

Rifkin immediately filed a second injunction

against the RAC for approving the industry test.5 3 9 Throughout the year 1984, the incessant presence of Jeremy Rifkin was a perpetual thorn in the sides of all those who promoted rDNA technology, and many of those involved in the negotiation of federal biotechnology policy as well.

He would continue to harass the

Administration with litigation and appearances at RAC meetings throughout the year.

While FET v. Heckler was pending, Rifkin widened

the scope of his attack against rDNA to extend beyond environmental matters, in hopes of pressuring the Administration, or the Congress, to regulate the rDNA companies out of business. For example, he opposed RAC review of any rDNA research approvals for the Department of Defense.

Rifkin also had presented the RAC with

a petition, signed by a wide variety of people whose names one would not expect to find together on the same page, Òthat efforts to engineer specific genetic traits into the germline of the human species should not be attempted.Ó5 4 0

Accompanying the petition was a document entitled

ÒThe Theological Letter Concerning the Moral Arguments Against

19-25. See p.20. 539 Ibid., p.25. 540 In Appendix II to the RAC minutes of February 6, 1984. U.S. Department of Health and Human Services, (1986). Documents Relating to "NIH Guidelines for Research Involving Recombinant DNA Molecules" September 1982 - September 1984, Office of Recombinant DNA Activities, NIH Publication No. 86-2863. See pp. 315-329, with list of petitioners. The list included names such as Pat Robertson of The 700 Club, Jerry Falwell of the Moral Majority, Reverend Ivan Kauffmann, General Secretary of the Mennonite Church, plus a host of Roman Catholic Bishops. George Wald, Nobel Laureate and member of CRG, and Sheldon Krimsky, also from the CRG, whose term on the RAC had expired in 1981, also signed the resolution.

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Genetic Engineering of the Human Germline Cells.Ó5 4 1

201 However, it seems

that the accompanying ÒTheological LetterÓ with its apocalyptic rhetoric may have represented only RifkinÕs position, not that of the signers of the more moderately worded ÒResolutionÓ requesting a ban on using rDNA to manipulate humans.5 4 2

RifkinÕs strategy was clever: to

propagate an already popular aversion to tampering with the human genome, so that later that year a prohibition against human genome tampering could be expanded to include the rights of all mammals to an unviolated species barrier. No chance to harass the RAC was overlooked as too insignificant. Rifkin even succeeded in forcing a change in the title of Section III of the RAC Guidelines from ÒContainment Guidelines for Covered ExperimentsÓ to ÒGuidelines for Covered ExperimentsÓ (despite Section IIIÕs reference only to contained experiments), because he insisted that NIH was no longer requiring containment of rDNA. was only the beginning for Rifkin.

Nevertheless, 1984

In Chapter Ten I will address more

Rifkin activities against rDNA. Back at the RAC

In June, there was more news of a strengthening of EPA presence on the RAC. Frances Sharples, former EPA fellow, had joined the RAC on 541

See Attachments II and III of the minutes of the RAC meeting of February 6, 1984, for all of these related documents. U.S. Department of Health and Human Services, (1986). Documents Relating to "NIH Guidelines for Research Involving Recombinant DNA Molecules" September 1982 - September 1984, Office of Recombinant DNA Activities, NIH Publication No. 86-2863. See pp.316-329. 542 Budiansky, Stephen, (1984). ÒAnatomy of a Pressure Group.Ó N a t u r e. v. (May 24) pp. 301-302. See p.302. The incident with the so-called ÒTheological LetterÓ also illustrates RifkinÕs gifted ability to create the illusion that his beliefs are widely held by credible people. By attaching it immediately after a resolution signed by theologians, the letter appeared to carry more weight, although it was not legally a misrepresentation of the intentions of the petitioners.

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June 1, 1984 as a full voting member, after pressure from Representative Al Gore.

She had also become a staff member of GoreÕs

subcommittee, according to Morris Levin, whom she apparently replaced.5 4 3 EPA.

Levin continued as a non-voting liaison to the RAC from

This deepening link between the RAC, the Congress, and the EPA

was possibly threatening to the AdministrationÕs position on how rDNA oversight should be handled. At the June 1 meeting, the RAC persevered in its business of reviewing proposals and revising and acting under the Guidelines to accommodate release into the environment.

Far from ready to consider

its own extinction as an overseer of rDNA release, the RAC had rejected the suggestions in the Talbot Boundaries Memo, as discussed in Chapter Seven.5 4 4

At the same time, the RAC was addressing the Gore Report

recommendations and withstanding the harassment of Jeremy Rifkin. In particular, on the RAC agenda for June 1 was the proposal from private firm, AGS for their version of Ice-Minus.

The AGS proposal had

already been postponed at the previous RAC meeting due to another restraining order issued at RifkinÕs request by an Appellate court, as described above.5 4 5

During the public discussion period, Rifkin cited the

recent FET v. Heckler decision prohibiting the RAC from approving any federally funded research involving release of rDNA into the environment, and questioned the sense behind the RACÕs consideration of private sector protocols for the same kinds of experiments.5 4 6 543

Henry

Minutes of the RAC Working Group on Release into the Environment, October 5, 1984, p.14. 544 The Talbot Boundaries Memo, dated December 21, 1983, from Deputy Director Bernard Talbot to William Gartland, Director of ORDA. RAC document number 1125. 545 This action was part of Civil Action No. 83-2714, (FET v. Heckler) . 546 RifkinÕs frequent demands were placed on the RAC agenda. He spoke often at

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I. Miller, the liaison representative from the FDA, his patience driven to its limit, declared that RifkinÕs constant objections were merely Òa manifestation of what the British journal Nature in the May 24th issue alluded to in describing Mr. Rifkin as someone whose nuisance to substance ratio is high.Ó5 4 7

After receiving RAC approval, AGS withdrew

its application from NIH and submitted it to EPA.5 4 8 By August, the NIH had completed a draft of the environmental assessment and Finding of No Significant Impact (FONSI) for the Lindow-Panopoulos version of the Ice-Minus project.

In defining its

purpose, the NIH statement read, Òin response to the CourtÕs decision, ... in view of the importance of the proposed experiment, ... [and] in order to remove any doubt about compliance with the National Environmental Policy Act [NEPA].Ó5 4 9

It was 65 pages in length. NIH sent copies of the

final documentation to over 3,000 additional parties who had requested it. Yet no public comments were forthcoming from anyone other than Rifkin and associates.

Crisis/Conflict: Division and Change at USDA - Summer 1984 Congress Turns Up the Heat

By summer, Congressman Gore was beginning to focus his attention on his run for the U.S. Senate.

However, there was never a shortage of

RAC meetings as a member of the public. 547 RAC meeting minutes of June 1, 1984, p.29. The N a t u r e article actually referred to the high nuisance-to-substance ratio of RifkinÕs lawsuit against Heckler et al., not to Rifkin himself. Budiansky, Stephen, (1984). ÒAnatomy of a Pressure Group.Ó N a t u r e. v. (May 24) pp. 301-302. See p.301. 548 Sun, Marjorie, (1985). ÒRifkin and NIH Win in Court Ruling.Ó S c i e n c e. v. 227 (March 15) p. 1321. 549 Draft of environmental assessment and FONSI for Ice-Minus, p.8. Under memo from the NIH legal advisor, Robert Lanman, dated August 29, 1984, requesting comments from ten experts. Tolin Archive, Box #2, Folder: 1984.

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pressure on the USDA from the Congress.5 5 0

204

The attention of A-RAC was

still focused on the Gore Committee when several other Congressional representatives jumped onto USDAÕs biotech bandwagon.

John Dingell

(D-MI), the formidable Chairman of the Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce, began asking detailed questions about the adequacy of USDAÕs ability to protect the environment from the possibility of runaway rDNA.5 5 1 In addition, Senator David Durenberger (R-MN) wanted witnesses for his own investigative hearing on environmental release of rDNA.5 5 2 Most importantly to A-RAC, the House Agriculture Committee was preparing to hold hearings in June, 1984 in order to collect information about rDNA to help in planning for appropriate changes to Title XIV of the 1985 Farm Bill.5 5 3

Title XIV was the section of the Farm Bill devoted to

funding for agricultural research.

One must never risk a political faux

pas when oneÕs appropriations purse is being counted.

With an almost

Orwellian aura, each action during 1984 would be carefully watched for political correctness. Ed Kendrick, Chair of the A-RAC, expressed frustration that the USDA was still perceived by outsiders as Òrelatively unconcerned and inactive

550

Minutes of the RAC meeting of October 5, 1984, p.14. Letter from Representative John Dingell (D-MI) to Orville Bentley, Assistant Secretary for Science and Education, USDA, dated August 2, 1984. Tolin Archive, Box #3, Folder: Dingell/Kendrick. 552 Letter from Senator Durenberger to Agriculture Secretary, John R Block, dated September 10, 1984. Tolin Archive, Box #3, Folder: Dingell/Kendrick. Durenberger was Chairman of the Subcommittee on Toxic Substances and Environmental Oversight of the Senate Committee on Environment and Public Works. 553 Memo from Hon. George E. Brown, Jr., Chairman of the Subcommittee on Department Operations, Research, and Foreign Agriculture of the House Committee on Agriculture, to Research, Extension, and Higher Education Leaders, dated April 9, 1984. Tolin Archive, Box #43, Folder: Brown Hearing - June 1984. 551

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in the arena of regulating biotechnology.Ó5 5 4

205

He related a brief history

of USDA participation in negotiating rDNA policy to the Assistant Secretaries of both the research and regulatory divisions.

Had no one

taken into account USDAÕs involvement with the RAC since before the original 1976 Guidelines had been issued? Nevertheless, a deepening philosophical chasm between research and regulatory divisions of the Department could not be hidden.

The A-RAC,

and especially CSRS, were forced to recognize that APHIS was about to play a much more significant role than before in order to keep the EPA at bay and in order to satisfy simultaneous demands from the Congress and the Administration. A-RAC Brokers the GAO Investigation 5 5 5

At the July 5, 1984 A-RAC meeting, members discussed the portion of the Gore Report which had asked for a General Accounting Office audit of USDAÕs authority to regulate release of rDNA.5 5 6

It was noted

with some dissatisfaction that, in attempting to provide the information required by the GAO audit, GAO was focusing on CSRS and research efforts, not on efforts of other agencies within the USDA nor on 554

Memo dated August 20, 1984 from Ed Kendrick to Assistant Secretaries Orville Bentley (research division) and C.W. McMillan (regulatory division). Tolin Archive, Box #3, Folder: Dingell/Kendrick. 555 Between the June 4 and July 5 meetings, the A-RAC had changed its name to the ARRC--Agricultural R e s e a r c h Recombinant DNA Committee, although no official reason was documented. It is likely that the change was made to prevent A-RACÕs being mistaken for a parallel to the RAC. Unlike RAC, A-RAC/ARRC was an internal committee, not held to the rules of the Federal Advisory Committee Act (P.L.92-463). See (39 FR 39306) November 6, 1974. National Institutes of Health. (1974). ÒNotices: Establishment of Committee.Ó Federal Register v. 39: 39306. November 6. A-RAC/ARRC was not required to include public representation or participation, nor was it required to keep detailed records or to publish its meeting notices, minutes, or decisions. Because the function of the panel did not change, in this dissertation I will continue to refer to the committee as the A-RAC for simplicity.

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regulatory efforts of the Department.

206

In addition, the A-RAC felt that

the Òquestions being posed lacked the distinction between performance of research and regulation of research.Ó5 5 7 The subtitle of one of the Congressional General Accounting OfficeÕs (GAO) reports is indicative of the GAOÕs impression of how the USDA was handling its biotechnology activities: ÒAgricultureÕs Regulatory System Needs ClarificationÓ.5 5 8 The GAO criticized the USDA on the following four points, paraphrased here: 1 . the DepartmentÕs failure to have formulated a welldefined oversight mechanism for biotechnology research and products despite the expected increase in rDNA projects. 2 . the practice of touting the benefits of biotechnology without sufficiently acknowledging risks or communicating the steps USDA had taken to minimize risks. 3 . failure to have resolved a control conflict between researchers and regulators within its own agency. 4 . the inadequacy of the A-RAC, a body regarded as having been given very little authority, with no sense of direction, nor any ability to provide leadership.5 5 9 The report also described three reasons for USDAÕs ÒhesitancyÓ to develop regulatory oversight at that time. 1 . the belief held by USDA officials that cumbersome regulations might stifle the development of the industry. 2 . reliance on a Òwait and seeÓ attitude while the White House was in the process of putting together the 556

See Gore Report Recommendation #7 in Appendix D of this dissertation. Minutes of the A-RAC meeting, July 5, 1984, p.1. Tolin Archive, Box #1, Folder: 6-4. 558 U.S. General Accounting Office, (1986). Biotechnology: Agriculture's Regulatory System Needs Clarification. GAO. Washington, DC. March. Report to the House Committee on Science and Technology. GAO/RCED-86-59. 559 Ibid. 557

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Coordinated Framework for regulation of biotechnology. (The development of the Coordinated Framework will be discussed in Chapter Nine.) 3 . the anxiety created by several legal actions filed by Jeremy Rifkin regarding rDNA, (Ònot so much because USDA officials believe the lawsuits [stood] to prove the research wrong or dangerous, but because of the time and resources they [believed] could be involved in such suits.Ó)5 6 0 The GAO acknowledged that the USDAÕs difficulty in facing these issues might have been the result of the agencyÕs having confidently engaged in careful, productive research for over 100 years with little public i n t e r e s t in what they were doing, let alone public scrutiny. The need to explain to outsiders USDAÕs reasons for confidence in its own informal research guidelines had never arisen before.5 6 1 GAO characterized USDA as Òsurprised by the excitement and concern about the new biotechnologies and ... not very effective in communicating to others their views on biotechnology.Ó5 6 2 Clearly the GAO, which worked for the Congress, was of the opinion that rDNA research and products of biotechnology should be treated as something special, if for no other reason than to acknowledge that the public thought it was so.

The GAO warned that by focusing on benefits

and not acknowledging that some scientists and others disagreed with USDAÕs enthusiasm for rDNA, the agency may precipitate the imposition of laws and regulations that were more restrictive than necessary, thus impeding the industryÕs progress.5 6 3

560 561 562 563

Ibid. Ibid. Ibid. Ibid.

See See See See

p.37. p.57. p.63. p.63.

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208

The APHIS Position

By the summer of 1984, APHIS was clearly interested in taking on rDNA regulation, even if it had to use existing statutes as would be required by the White House.

In the spring of 1984, when the Reagan

Administration began an effort to coordinate federal rDNA policy (see Chapter Nine), Terry L. Medley, then a senior attorney advisor for plant protection in the USDAÕs Office of the General Counsel, had already been avidly perusing the literature in biotechnology.

He had even begun

attending many of the Cabinet Council meetings at the White House with Karen Darling, (Deputy Assistant Secretary for Marketing and Inspection), who had recruited MedleyÕs assistance as early as 1982.5 6 4 The APHIS responsibility was clear to Medley--that was to make sure that products which were developed using the new technology met the same safety standards as conventional products.5 6 5

Unfortunately, for

products other than those to control plant pests, there were few relevant safety standards available. An indication of strong opposition to EPA leadership in rDNA oversight, as well as a fear that the Congress might take authority from USDA and give it to the EPA, was found in a draft briefing memo from the private collection of an APHIS employee. ÒIn the event that Congress develops legislation for EPA to take leadership, USDA should oppose that leadership along with other Federal Agencies. ... If opposition to EPA leadership fails, USDA should seek to have its existing applicable Acts exempted from EPA regulation. Further, ... USDA should resist any attempt by

564

Interview with Terry L. Medley, J.D. former Director of USDA-BBEP and Administrator of APHIS, USDA. Washington, DC (December 11, 1997). 565 Ibid.

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EPA to drop the 10-acre [research] exemption now in FIFRA.5 6 6 Alluding to intra-agency disagreement, in addition to the overt interagency resentfulness, the memo continued: ÒThere will be some opposition within the USDA to the regulation of Recombinant DNA technology in Agriculture based on the opinion that the risk is so low that additional regulation is not needed. This is especially true if EPA regulates. However, even if USDA regulates, there will be some opposition.5 6 7 The most controversial matter between EPA and USDA was the EPAÕs redefinition of rDNA as a Ònew chemical.Ó

The opposition within the

USDA to which the memo referred was likely the CSRS opposition to APHIS regulation of rDNA r e s e a r c h.

APHIS felt that public confidence in

the safety of rDNA products o r research would be difficult to earn in the wake of all the media hype generated by Rifkin, unless there were strict public oversight--at least in the early stages. The A-RAC had been collecting intra-agency reports listing existing laws and regulations that could cover rDNA from various agencies within USDA, as requested through McMillan by ReaganÕs Cabinet Council.

By August, however, the DepartmentÕs official position had not

yet solidified.

One thing was certain.

The A-RAC Òfelt strongly that the

regulatory and research authorities must be kept separate.Ó5 6 8 Karen 566

This undated, unsigned briefing memo, entitled ÒComments on the Gore Report and Suggestions for USDA Positions on Recombinant DNA and Related Technology,Ó found in the personal files of an APHIS employee, was most likely written in the spring of 1984, and most likely originated at APHIS, judging by contents. MEJ personal archive. Folder: Ib. 567 Ibid. 568 Minutes of the A-RAC meeting, July 5, 1984, p.1. Tolin Archive, Box #1, Folder: 6-4.

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Darling stalled for time at the Cabinet Council Working Group meetings. In a memo to other Administrators, Darling wrote, ÒOSTP again requested rDNA Ôguidelines.Õ I stalled and requested that we get together with Bernadine [Healy] prior to the next meeting.Ó5 6 9 The CSRS Position

A year earlier, in the summer of 1983, the Gore committee had followed its June 22 hearing with questions directed toward various agencies regarding the adequacy of federal oversight of rDNA.

A CSRS

draft of answers for Ed Kendrick (A-RAC chairman) to use when responding to some of these questions elucidates the CSRS position.

It

was CSRSÕs collective opinion that although USDA had Òvery limited authority to regulate the introduction of [rDNA organisms]Ó that Ò[t]here should not be a perception that this limited authority is not adequate at this time.Ó5 7 0

At the same time, CSRS recognized that self policing by

industry might not provide adequate public or private protection. Guidelines were still seen as a necessary component of oversight.5 7 1 These answers to the Gore Committee represent a clear indication that CSRS did not want the regulatory division of USDA to take over rDNA oversight, particularly of rDNA r e s e a r c h.

CSRS personnel reasoned

that there was precedent for separating research from regulatory oversight with respect to medical applications of rDNA. 569

FDA regulated

Memo to USDA Assistant Secretaries and Administrators from Karen Darling, August 15, 1984. Tolin Archive, Box #1, Folder 3-4, Cabinet Council. OSTP is the Office of Science and Technology Policy at the White House. 570 See p. 2 of attachment to memo from Estel H. Cobb, Acting Deputy Administrator of Plant and Animal Sciences, CSRS, to C. I. Harris, Acting Administrator of CSRS, subject: Responses to Gore Committee, dated August 11, 1983. Tolin Archive, Box #1, Folder: 6-2. 571 Ibid., p.3.

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only rDNA products, not the research that led to the development of those products.

Research involving rDNA (but not products) was

overseen by the RAC. Both FDA and NIH are in the U.S. Department of Health and Human Services.

However, that the CSRS knew its own

perspective was not ubiquitous is evident from the cover memo attached to the drafted answers.

The memo identified the attached

views as belonging to ÒCSRS collectively,Ó which Òreflect a broad scientific community including industry, university, and some other federal agencies.Ó

However, the memo added, ÒWe did not review with

other USDA agencies, assuming that was not our purpose.Ó

Thus, CSRS

implied that its own view was broadly held, but qualified its position by admitting that it may not have agreed with the position of APHIS.5 7 2 Certainly USDA researchers felt that biotechnology was simply another tool in the tool box.

It was of course a more powerful and

precise means of manipulating the genomes of agricultural organisms, but not something so different that it was deserving of special regulatory attention. argument.

Medical researchers had followed the same

Aside from philosophical differences, another reason for

CSRSÕ opposition to APHIS regulation of rDNA research was the enormous amount of potential research money that would be expended in regulating what CSRS personnel considered to be potential risks. Ironically, a strong push for public oversight of rDNA research through regulation, as APHIS had proposed, would threaten the ability of public academic research institutions to be able to afford to conduct research. Sue Tolin recollected,

572

Ibid.

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ÒOne of John FulkersonÕs primary goals was to get research dollars into the Experiment Station System so we could learn more about [rDNA]. He said, ÔIf the dollars went to the regulatory side of the ledger, it would take funds from research.Õ If I heard him say that once, I heard him say it a hundred times.5 7 3 The research side recognized that it would have to do something to display a greater presence and an interest in taking environmental effects seriously, before the regulatory side diminished CSRS leverage. Initiated by Fulkerson, the Land Grant System proposed its own risk assessment project.

Among the early 1984 proposals to nip the impact

of biotechnology in the environmental bud was a program with the unfortunate acronym ÒNaBASÓ.

The National Biotechnology Assessment

System (NaBAS) was quickly changed to the National Biological Systems Impact Assessment (NBSIA) in August, and to the National Biological Impact Assessment Program (NBIAP) in November, 1984.5 7 4 NBIAP would provide a computerized database for monitoring and feedback.

It was designed to cover commercial applications as well as

research and to be integrated with the proposed federal framework for the regulation of biotechnology that the Administration was preparing. Yet it placed control of rDNA risk management oversight squarely on the shoulders of the Land Grant Universities--a network of about 3,000 573

Personal communication with Sue A. Tolin, Ph.D. Professor of Plant Pathology, Physiology, and Weed Science, Former USDA representative to the NIH-RAC and OECD. Virginia Tech (various dates in 1998, 1999). 574 The Tolin Archive contains drafts of NaBAS dated May 9, 1984, NBSIA dated August 2, 1984, and NBIAP dated November 6, 1984. Tolin Archive, Box #1, Folder: 8-2. See final draft of the NBIAP proposal in the ÒGold Nugget.Ó Committee on Biotechnology, Division of Agriculture, NASULGC, (1984). E m e r g i n g Biotechnologies in Agriculture: Issues and Policies: A National Biological Impact Assessment Program, 'Chapter 6'. National Association of State Universities and Land Grant Colleges. March, 1985 Update. Progress Report. 3.

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213

research sites across the country--of which CSRS was the federal coordinating body.5 7 5

Quasi-quiescence: Giving in to Reagan - Autumn 1984 USDA Confronts EPA

During the autumn of 1984, a great deal of time and effort was spent by USDA on redrafting policy statements for the AdministrationÕs Coordinated Framework for Regulation of Biotechnology.

The EPA had

turned in a draft of its policy statement on rDNA in August of 1984, and the FDAÕs statement was near completion.5 7 6

At the August 26, 1984

meeting of ReaganÕs Cabinet Council Working Group on Biotechnology, there had been Òstrong pressure for USDA to provide a draft of its guidelines as soon as possible.Ó5 7 7

Yet, the A-RAC still had not been able

to bring a divided house to agree on a unified departmental statement. As late as October 25, A-RAC chairman, Ed Kendrick, sent a memo of entreaty to A-RAC members to act quickly in the production of a final draft of USDAÕs policy statement as requested by the Administration.5 7 8 Drafts were shared for comment both within and among the various federal agencies.

575

The main area of accord within USDA was a unified

Fulkerson, John F., (1987). ÒBiological Impact and Assessment: Biological Potentials Over Time.Ó BioScience. v. 37 (3) (March) pp. 187-189. The NBIAP program is still in operation today as ÒInformation Systems for BiotechnologyÓ at the Virginia Polytechnic Institute and State University, a Land Grant University in Blacksburg, Virginia. http://www.nbiap.vt.edu/ 576 Memo from C.I. Harris, Associate Administrator, to Orville Bentley, the Assistant Secretary of USDA Science and Education, dated September 28, 1984. Tolin Archive, Box #31, Folder: Meeting Minutes, Cabinet Council, 1984. 577 Ibid. 578 Memo from Ed Kendrick to members of ARRC (new name of A-RAC), dated October 25, 1984 regarding the October 23 meeting of the Cabinet Council Working Group on Biotechnology. Tolin Archive, Box #31, Folder: Meeting Minutes, Cabinet Council, 1984.

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214

opposition to the EPAÕs effort to regulate rDNA as a Ònew chemical.Ó On October 17, 1984, in a pre-emptive move before the White House could pull the regulatory rug out from under it, the EPA had published an interim policy on small scale field testing of microbial pesticides in the Federal Register.5 7 9

EPA would require notification prior to all field

tests of microbial pesticides to determine whether an experimental use permit would be required.

If either nonindigenous or rDNA microbials

were involved, this ruling would even include small scale research plots of less than ten acres.

Consider the added financial and time

requirements for a graduate student at an agricultural college to complete a program of study if he or she had to submit large amounts of data to one or more federal agencies and then wait months or years for permits. The interim policy, which became the centerpiece of EPAÕs position statement for the AdministrationÕs proposed Coordinated Framework for Regulation of Biotechnology (see Chapter Nine), endures today as EPA still has not negotiated a final policy.

Although chemical pesticides

could be tested for research purposes on acreage of 10 acres or less without a special permit, the decision to regulate rDNA pesticides differently was made based on the assumption that living microbials could replicate and spread beyond the test site, no matter how small the test site might be.5 8 0

579

This would be the case even though the research

(49 FR 40659) October 17, 1984. Advance copies of this document were distributed at the October 5, 1984, meeting of the RAC Working Group on Release into the Environment. EPA had asked the subcommittee for their comments before publishing in the Federal Register for general comment. Attachment X to the minutes of October 5, ÒMicrobial Pesticides: Interim Policy on Small Scale Field Testing.Ó 580 (49 FR 50856) December 31, 1984 See p.50885.

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215

may not result in a commercial product, for example, if it were being done only to gain new knowledge about life processes.5 8 1 Curiously, in 1977, President CarterÕs EPA Administrator, Douglas Costle, had recommended that legislators consider placing statutory authority for regulating biotechnology somewhere other than EPAÕs TSCA statute.

Costle cited Òinterpretive and conceptual problemsÓ with

using TSCA, for example, in defining DNA in living things as Òchemical substances.Ó5 8 2

Costle suggested that by enacting comprehensive

legislation to regulate all aspects of rDNA technology from research to commercial applications, a more effective oversight would be achieved.5 8 3

Had Congress been prepared to legislate at that time, a

unified Democratic government (Senate, House, and Presidency) might have passed a comprehensive biotechnology package into law. so often plays a pivotal role in policymaking.

Timing

In 1984, with a

Republican led Senate and an Administration opposed to new regulations, EPAÕs legal staff set to work on finding a way to make TSCA Òfit.Ó A document which exhibits the profound difference in perspective between EPA and the USDA is the October 16, 1984 draft statement entitled ÒUSDA Comments on Draft Statement of Policy Regarding 581

Tolin, Sue A. and Anne K. Vidaver, (1989). ÒGuidelines and Regulations for Research with Genetically Modified Organisms: A View From Academe.Ó A n n u a l Review Phytopathology. v. 27 pp. 551-81. See p.567. 582 Letter from Douglas M. Costle, EPA Administrator, to Senator Adlai E. Stevenson, Chairman of the Subcommittee on Science, Technology, and Space, of the Senate Committee on Commerce, Science, and Transportation, dated December 9, 1977, in U.S. Congress, Senate, Science Committee on Commerce, and Transportation, and Technology Subcommittee on Science, and Space,, (1978). Recombinant DNA Research and Its Applications. U.S. Government Printing Office. Washington, DC. August. oversight report. 73/7. R24. See p.88. 583 Letter from Douglas M. Costle, EPA Administrator, to Senator Adlai E. Stevenson, dated December 9, 1977, in Ibid., at p.89.

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Certain Novel Microbial ProductsÓ5 8 4

216

Although the draft document was

unsigned, there is published evidence to suggest it was directed to the Administration by A-RAC chairman, Ed Kendrick, in criticism of the EPA policy.5 8 5

The draft, which speaks for USDA in general, listed three main

concerns with the EPA draft policy statement regarding rDNA microbial products: risk perception, technical terminology, and comparative jurisdiction. First was the perception that by using FIFRA and TSCA to regulate rDNA microbial products, EPA presumed that all rDNA derived products were very dangerous and were to be treated as if they were potential cancer causing chemicals or other toxic substances.

Removal from the

list of dangerous articles would be only on a case-by-case basis.

The A-

RAC document maintained that no scientific argument had been presented to support the conclusion that genetic modification produces adverse effects.5 8 6

On the other hand, it was argued that many years of

experience with experimental introduction of familiar, non-recombinant 584

Unsigned draft entitled ÒUSDA Comments on Draft Statement of Policy Regarding Certain Novel Microbial ProductsÓ dated October 16, 1984. Tolin Archive, Box #1, Folder: 6-4. Note that government insiders generally know the content of other agenciesÕ Federal Register announcements prior to publication because drafts are circulated for comments. In this way, agencies can avoid public ridicule by determining and correcting weaknesses in their proposals while they are still labeled Òpreliminary.Ó 585 The draft statement, ÒUSDA Comments on Draft Statement of Policy Regarding Certain Novel Microbial Products,Ó is an original print, in a font and on a type of paper not unlike that of A-RAC documents in the Tolin Archive. There is also reference to such a document, accurately summarized, citing the A-RAC chairman as the source, in one of the GAO audit reports. U.S. General Accounting Office, (1986). Biotechnology: Agriculture's Regulatory System Needs Clarification. GAO. Washington, DC. March. Report to the House Committee on Science and Technology. GAO/RCED-86-59. See p.47. Another document, a memo to Kendrick from Martin Rogoff of ARS dated October 4, 1984, (Tolin Archive, Box #1, Folder: 64) outlines two of the three criticisms that appear in the later document, which in all probability was the one sent by Kendrick. 586 Unsigned draft entitled ÒUSDA Comments on Draft Statement of Policy Regarding Certain Novel Microbial ProductsÓ dated October 16, 1984. Tolin

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217

crop plants allowed for extrapolation to the relative safety of rDNA products using those plants.

Note that there was little other evidence

available to show that rDNA products would n o t produce adverse effects, because the experiments that would have provided the scientific support of the presumption of safety had not yet been permitted. Curiously, agricultural researchers often rejected the EPAÕs use of extrapolation from experience with kudzu and gypsy moth as an example of unintended adverse effects of the introduction of a novel organism.

There is here an ironic difference between the approaches of

EPA and USDA regarding risk: The philosophically liberal EPA, acting conservatively, presumed that rDNA products were guilty until they were proven innocent on a case-by-case basis.

Meanwhile, the

philosophically conservative agricultural community, acting liberally, presumed innocence, without the benefit of testing, until guilt was proved. A second concern expressed in the A-RAC draft opinion on the EPAÕs policy was over terminology. chemical substances.Ó

EPA had defined rDNA organisms as Ònew

Hampered by the Reagan rule of Òno new rules,Ó

all agencies wanting to regulate rDNA would have done their best to stretch existing statutes to cover rDNA by manipulating definitions. Creative interpretation of existing law was the only way that individual agencies could grab jurisdictional turf or advance a particular political agenda, such as embracing environmentalism or conserving traditional methods of land management.

EPAÕs stretching of the definition Ònew

chemical substancesÓ to include rDNA so that TSCA would cover biotechnology was anathema to USDA. Archive, Box #1, Folder: 6-4.

EPA had defined DNA as a

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chemical and rDNA as not naturally occurring.

218

It appeared that EPA

wanted to regulate rDNA microorganisms based on the process by which they were produced, not by the intended use of the product.5 8 7 Third, was the A-RAC opinion that EPAÕs policy was encroaching upon USDAÕs jurisdiction, for example, by not excluding microbial pests that were already regulated under the Federal Plant Pest Act, or by claiming jurisdiction over veterinary microbials such as rDNA vaccines. Reflecting what would become the AdministrationÕs dictum, the position presented in the A-RAC draft was that products, not process, should be regulated, as expressed in this counter-statement to EPAÕs position: Ò[T]he proposed use of the microorganism should determine which agency or department should have jurisdiction regardless of whether the organism is naturally occurring or new.5 8 8 EPAÕs plan to regulate small scale releases of less than 10 acres was of special interest to

the agricultural research community.

An

unidentified scientist at the Agricultural Research Service in USDAÕs research division was quoted saying, ÒThis is not a trivial requirement because the background information is so extensive and inclusive...that it will be unnecessarily time-consuming and costly to obtain such information.Ó5 8 9 Imagine if you will, the impression this scenario might make on policy makers. 587

Because the technology was relatively new, and because

Ibid. Ibid. 589 The unnamed ARS scientist was interviewed for the GAO audit that was imposed on USDA by the Gore Committee. U.S. General Accounting Office, (1986). Biotechnology: Agriculture's Regulatory System Needs Clarification. GAO. Washington, DC. March. Report to the House Committee on Science and 588

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219

release of rDNA into the environment had been prohibited by the NIH Guidelines (for lack of information about potential hazard), there had been no controlled risk assessment studies with rDNA organisms to determine whether or not the outdoor release of rDNA would have had adverse effects on human health or the environment.

Yet, EPA felt

strongly enough that there was a small chance of devastating effects to warrant extreme caution.

Conversely, some members of USDA,

operating with the same absence of actual test data (because they were not permitted to collect it), were convinced that adverse effects were grossly overestimated and that such caution was n o t warranted. Both used data extrapolated from scenarios they understood best.

To a

completely disinterested third party observer, the superficial arguments about risk presented by either side were weakly substantiated and appear to have been based on which facts participants preferred to believe were true so as not to disrupt their predilections.

That is, evidence was given credibility based on how it fit

in with what was already believed to be true.

Personal values and

experience (world view) were determining scientific opinion.

(See

Chapter Twelve.) Forced to Unite

Biotechnology presented agricultural researchers with a unique problem that biomedicine did not have to face.

The delay in USDAÕs

reaching a consensus statement may have in part been caused by the greater complexity of issues that USDA had to consider compared to the biomedical community.

For example,

Technology. GAO/RCED-86-59.

See p.47.

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220

· The need to do basic research outdoors, despite

Guidelines that prohibited such activity unless case-bycase exceptions were given, · The need to use living organisms capable of survival in the environment, despite the public fear generated by the 1974 moratorium and the prohibitions in the Guidelines, and, · The greater number and variety of species involved. In addition, the research side of USDA was staffed primarily with scientists; the regulatory side with attorneys.

Without getting into the

argument about whether someone who was Òonly a lawyerÓ could understand the intricacies of rDNA analysis or whether someone who was Òmerely a scientistÓ could fathom the perplexity of political negotiation, suffice it to say that there were profound differences in professional perspective.

Even within research agencies, there were

differences in perspective brought about by different personal world views. Competing interests were evident both within the USDA, and between the EPA and USDA.

The House Democrats had already

indicated their preference for stronger oversight of rDNA.

If the

competition were between agencies w i t h i n the USDA, research dollars might be sacrificed to pay for regulatory programs.

On the other hand,

Congressional appropriations, always initiated in the House of Representatives, might favor the winner in a competition for jurisdiction between the USDA and EPA.

Thus the unification of the

USDA on a plan for regulating agricultural biotechnology may have been prompted more by jurisdictional jealousy than by any intra-agency agreement.

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221

It is also important to note, as elucidated by this account of the rDNA release controversy, that although a federal agency might have spoken with one official voice--usually, but not always, in concert with the Administration--there were actually many opinions present among the individuals who worked there.

Leadership comes and goes, but huge

bureaucratic institutions change very slowly if at all.

Career

bureaucrats in the Executive Branch, each with his or her own personal views and ways of approaching problems, interpret and apply the laws made by Congress, and make and enforce regulations within the mandates set by the White House leadership.

The resulting institutional

inertia in large agencies slows their ability to keep up with the changing demands of new technologies.

The development of biotechnology policy

was limited by ReaganÕs Òno new regulationsÓ mandate.

However, there

were times when an artful interpretation of existing law by career bureaucrats provided a means of circumventing the intent of the Administration.

Summary The internal debate at the USDA exhibited all the same periodic stages as the Release Era within which it took place, but on a microlevel.

During the gestation period in early 1984, the EPA was preparing

to take over regulation of rDNA release under TSCA and FIFRA, but as yet had very little experience or expertise in the area of molecular biology. The USDA, with CSRS in the lead, continued to support the RACÕs oversight of release into the environment, hoping to assist the NIH in setting conditions for outdoor releases for research before more

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onerous regulation became a necessity.

222

A threshold was crossed when

APHIS began to suggest its own regulatory options. The Congress was pressuring for more public oversight of rDNA releases, while laying bare the inadequacies of USDA (through hearings and the GAO audit) to do the job.

Meanwhile, pressure from the White

House Cabinet Council for USDA to participate in the regulation of rDNA release set one internal agency against another, giving the outward appearance that the Department was disorganized, had not made up its

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collective mind, or simply wanted no part of rDNA oversight.5 9 0 Animosity developed between the research and regulatory branches of USDA as they tried to arrive at a consensus policy statement for the Department.

Philosophical differences about the necessity of rDNA

regulation polarized members of the agricultural community as they entered a summer crisis/conflict period. For example, CSRS researchers stood by their science-based convictions that rDNA organisms did not present any unique hazards which were not already present in the parent organisms. regulation might imply that risks were high.

Strict

Furthermore, they argued

that knowledge gained with familiar crops and microorganisms could be extrapolated to include rDNA organisms.

On the other hand, USDA

personnel who were more familiar with regulation, public policy, and public reactions were likely to favor an oversight approach that would allow the industry to grow while calming public fears. If it takes a common purpose to draw two warring factions together in cooperation, that common purpose was to stop the EPA from stepping on USDAÕs regulatory toes.

The threat that EPA would regulate

agricultural research as well as the possibility of stealing jurisdiction from APHIS for agricultural products of rDNA finally brought the USDA to a final policy statement: rDNA research and products would not be regulated any differently from traditional research and products.

This

action allowed the internal debate to decline into a temporary quasiquiescence as the year drew to a close.

It was another example of

resolution illusion, however, because the underlying philosophical

590

Ibid.

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differences within the Department had not been resolved, just laid aside while confronting a common threat. On New YearÕs Eve of 1984, possibly in order to forestall the Congress from authorizing the EPA to take control of rDNA, the Reagan Administration published a Proposed Coordinated Framework for Regulation of Biotechnology.

The genesis and development of the

AdministrationÕs policy will be covered in the next chapter.

CHAPTER NINE: THE REAGAN ADMINISTRATION AND THE COORDINATION OF FEDERAL OVERSIGHT FOR BIOTECHNOLOGY Introduction Having inherited an economy in recession from the Jimmy Carter Administration, President Reagan devised Òa new political and economic synthesisÓ which combined the Òelements of Ôsupply sideÕ economic theory with a political philosophy propounding a much more constricted role of government.Ó5 9 1

While unemployment, fear of war, and the

economy in general continued to top the list of American worries throughout the 1980s,5 9 2 the Republican Administration responded to the calls for economic relief by reducing the tax burden on corporations and wealthy individuals to stimulate the economy and by reducing federal spending on social programs.5 9 3 The Republican Reagan Administration viewed science and technology as tools with which to achieve national goals. among those goals was international competitiveness.

Primary

However, before

the U.S. could engage in meaningful dialogue about biosafety issues with the international community it first had to get its own house in order. The AdministrationÕs attempt to resolve the rDNA debate culminated in the Coordinated Framework for Regulation of Biotechnology. 591

Barfield, Claude E., (1982). Science Policy from Ford to Reagan. Washington, DC, American Enterprise Institute for Public Policy Research. See p.37. 592 Ragsdale, Lyn, (1996). Vital Statistics on the Presidency: Washington to Clinton. Washington, DC, Congressional Quarterly. See pp.239-240. 593 Microsoft Corporation, (1996). Microsoft Encarta 97 Encyclopedia Deluxe Edition, Version 1.0. Redmond, WA.

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Although many attempts were made in the interim, especially by the research division of USDA, to assist in revising the Guidelines to cover deliberate release of rDNA in a way that would preclude regulation by other agencies, once the Administration sanctioned the idea of a Coordinated Framework, the agency turf wars accelerated and there was no turning back to voluntary guidelines as the sole means of federal oversight for rDNA.

The Reagan Years594 ÒNo New RulesÓ

When Reagan entered the White House in 1981, he unquestionably wanted a less intrusive federal government, especially where the economy was concerned.

One of his earliest actions was Executive Order

(E.O.) #12291 of February 17, 1981. for regulatory relief.

This action initiated ReaganÕs plan

This sweeping order, which carried the power of

law until revoked, required review of all new and old regulations for impact on the economy, "to reduce the burdens of existing and future regulations, increase agency accountability for regulatory actions, (and) provide for presidential oversight of the regulatory process.Ó5 9 5 In other words, Reagan wanted an across the board ÒEconomic AssessmentÓ akin to the ÒEnvironmental AssessmentÓ required by the National

594

When the name of a president is attached to a philosophy, policy, plan or platform, it is usually not attributable solely to the individual who is the president, but to the entourage of people in his Administration who run the various parts of the government. Because of the necessity for delegating most tasks, the president himself frequently knows little or nothing about the details of a specific program, other than its overall correspondence to a handful of broad personal goals for his Administration. This leaves ample room for interpretation of policies by staff. 595 (46 FR 13193). February 19, 1981.

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Environmental Policy Act of 1969.

227

For purposes of enforcing this Order,

all agency headsÕ actions were subject to the direction of the Presidential Task Force on Regulatory Relief. Whereas E.O. #12291 slowed any regulatory process then under way, ReaganÕs E.O. #12498 of Jan. 4, 1985 allowed the Director of the Office of Management and Budget (OMB) to interfere in any regulatory process even before it even got started.5 9 6

The directive put the OMB in charge

of ensuring that all regulatory actions were consistent with the goals of the Administration.

Any disagreements would be referred directly to

the president or his designee.

Not only would this action keep potential

renegade agencies in line, but in this manner, the White House could also prevent the legislative branch from accomplishing much in the way of regulating biotechnology as a special entity simply by saying to the agencies, ÒYou cannot make a regulation we don't like--no matter what Congress says.Ó5 9 7

Note that E.O. #12498 was promulgated within days

of the December 31 Proposed Coordinated Framework and within a few months of EPAÕs announced interim policy. Reagan had an intense interest in economic expansion and growth, in international security and competitiveness, and in increasing the autonomy and capability of the private sector.

Through Executive

Orders and other actions, the Reagan Administration made it perfectly clear that any new federal rules which hindered industry and economic development, especially where international competitiveness was (50 FR 103). January 4, 1985. In E.O. #12866, Regulatory planning and review, signed on September 30, 1993, Democratic President William J. Clinton revoked both E.O. 12291 and 12498 (58 FR 51735). 597 Montague, Peter, (18 September 1991). ÒThe Secret Government WithinÓ. Rachel's Environment and Health 596

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concerned, would not be tolerated.

228

The Reagan mantra became, ÒNo

new laws!Ó and by extension, ÒNo new regulations!Ó

To sustain his pro-

technology position, Reagan had enjoyed the enduring support of a Republican Senate for the first six years of his two terms.5 9 8 Because of ReaganÕs firm stand on Òno new rules,Ó it would have been unlikely that any new legislation establishing authority for a process-based oversight for biotechnology would have passed both Houses of Congress into law. The unlikelihood of passage, however, does not preclude the authoring of bills by Members of Congress who wish to take a public stand on an issue.

Bills were offered and hearings were held on rDNA

technology throughout the 1980s.

Ironically, the knowledge that a

piece of legislation is unlikely ever to pass or even to come to a vote may actually increase the likelihood of MembersÕ use of high profile issues like the rDNA controversy for ÒposturingÓ purposes.

Sometimes,

an effective way for the Congressional leadership to signal policy positions to the Administration without passing legislation is simply to hold high profile hearings.5 9 9 Interestingly, the Òno new rulesÓ decree appears to have been limited only to those regulations that would have been contrary to Republican Party values.

One of the most restrictive regulations ever to come out

of the Reagan era was the so called ÒGag rule.Ó The 1988 ÒGag RuleÓ prohibited the offering of counseling or referral for the use of abortion Weekly, #251 (Environmental Research Foundation). Accessed November 9, 1998. 598 Thurber, James A., (1996). ÒAn Introduction to Presidential-Congressional RivalryÓ in Rivals for Power. J. A. Thurber, ed. Washington, DC. Congressional Quarterly. p. 266. Overall, the Senate from 1981 through 1984 supported the presidentÕs position (on issues the president took a stand on) over 80% of the time. Ornstein, Norman J., Thomas E. Mann and Michael J. Malbin, (1994). Vital Statistics on Congress, 1993-1994. Washington, DC, Congressional Quarterly. See p.196. 599 Interview with L. Christopher Plein, Ph.D. Assistant Professor of Public

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as a method of family planning at any clinic which received federal funding.6 0 0

The ÒGag RuleÓ was left in place by Republican George Bush,

and finally revoked as soon as Democrat William Jefferson Clinton entered the White House.

The effect of world view on policy making is

certainly not limited to biotechnology. Science Policy Under Reagan

Science and technology were perceived by the first of two Reagan Administrations Òas tools to achieve certain national goals.Ó6 0 1 George A. (Jay) Keyworth, ReaganÕs chief science advisor and director of the Office of Science and Technology Policy (OSTP), testified before a House Committee on Science and Technology on December 10, 1981 that the Reagan AdministrationÕs view of the role of modern science and technology emphasized international competitiveness, federal support for scientific (primarily basic), research, and reduction of government interference with business to enable them to take over technology development.

Keyworth testified that,

Ò[T]odayÕs federal role in science and technology must be different from that which has prevailed since World War II. ... [It must be] appropriate to a national mood which calls for increased vigor and acceptance of responsibility by individuals and organizations in the private sector and decreased involvement by the federal government in many of our affairs.6 0 2 Administration, West Virginia University (October 28, 1994). 600 Code of Federal Regulations, Public Health Title 42. 1992 ed. Chapter 1, ¤ 59.1 et seq. Authority: 42 U.S.C. 300 a-4. 601 Barfield, Claude E., (1982). Science Policy from Ford to Reagan. Washington, DC, American Enterprise Institute for Public Policy Research. See p.40. 602 U.S. Congress, House of Representatives, Committee on Science and Technology, (1982). U.S. Science and Technology Under Budget Stress. U.S. Government Printing Office. Washington, DC. December 10, 1981 and February 2,3,4, 1982. Hearings. 97/118. See p.14, 15.

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Clearly the Reagan Administration was opposed to burdening corporations with Òcapricious regulationsÓ that would engender the wasting of industrial R&D budgets on Òdefensive R&D, aimed at regulatory complianceÓ instead of Òmore productive channels of research.Ó6 0 3

Note the similarity to the position taken by CSRS scientists,

described Chapter Eight, who were averse to the channeling of limited funds from research to regulatory sides of USDA. Likewise, John McTague, the Acting Director of OSTP during ReaganÕs second Administration, testified in a House Science committee hearing (February 6, 1986) that the Administration was supportive of university/industry research relationships to Òbenefit both partners,Ó and that it was Òaggressively pursuing an initiative to establish university-based, multidisciplinary, problem-focused, science and technology centers aimed at areas of broad national needs and relevant to industrial technology.Ó6 0 4

McTague also told the committee that the

country Òmust have ... the technological and human resources to compete effectively in an increasingly international marketplace.Ó6 0 5 In the case of agricultural biotechnology, the bulk of which research is done at federally funded Land Grant institutions, the combined testimonies of Keyworth and McTague would have been interpreted by

603

Keyworth testimony, in U.S. Congress, House of Representatives, Committee on Science and Technology, (1982). U.S. Science and Technology Under Budget Stress. U.S. Government Printing Office. Washington, DC. December 10, 1981 and February 2,3,4, 1982. Hearings. 97/118. See p.13. 604 U.S. Congress, House of Representatives, Committee on Science and Technology, (1986). Science and Technology Posture Hearing with the Director of the Office of Science and Technology Policy (John P. McTague, Acting Dir.). U.S. Government Printing Office. Washington, D. C. February 6. Hearing. 99/151. See p.6. 605 Ibid., See p.6, p.4.

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liberal political activists as constituting a blessing on the use of public funds for private sector profit, with no public oversight permitted. Given the political and economic milieu of both Reagan Administrations, it is no surprise that the fledgling biotech industry should find shelter under White House wings.

John Cohrssen, former

Regulatory Counsel for the OSTP and Project Director of the Council on Environmental Quality in the Reagan White House recalled, ÒCertainly Reagan was very pro-biotech.... There was also the view that this was an emerging technology. We wanted it to be an American technology.Ó6 0 6

In the mid-1980s, the Reagan Administration was forced to respond to the domestic turmoil in biotechnology oversight with a concerted effort to satisfy demands for environmental and consumer protection without hamstringing the industry.

The result was a document called

the Coordinated Framework for Regulation of Biotechnology, the details of which will be discussed later in this chapter.

The development of

this product-oriented framework for oversight, which required the cooperation of several federal agencies with differing opinions on how it should be done, was coordinated by the Office of Science and Technology Policy (OSTP) in the Executive Office of the President. The Domestic Policy Council Working Group on Biotechnology

The Reagan White House had several Cabinet level policy councils. As described in Chapter Eight, it was in March, 1984 that the chief of 606

Interview with John Cohrssen, J.D. former legal counsel, Cabinet Council Working Group on Biotechnology, Reagan Administration. Washington, DC

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the White House OMB, Christopher DeMuth, proposed a Cabinet Council working group to confront EPAÕs claim to jurisdiction in regulating biotechnology products under the Toxic Substances Control Act.6 0 7 The matter was subsequently referred to the Cabinet Council on Natural Resources and the Environment, which formed an interagency working group in April, 1984 called the Domestic Policy Council Working Group on Biotechnology (hereafter, the Working Group).6 0 8

The Working Group

was established to consider whether rDNA products would pose greater risks than those developed by more traditional techniques.6 0 9 Duties included reviewing existing policies and clarifying a path that a company with a new product would have to follow in order to meet health and safety requirements.6 1 0

Of course, the impact of any

decisions on the economic health of the nation was mandated by ReaganÕs E.O. #12291 and had to be considered as well. Although only a few members of the Working Group will be introduced throughout this chapter, it should be noted that it was a very large council, consisting of high level presidential appointees.

The

membership included Assistant Secretary level representatives from the Departments of Interior, State, Justice, Agriculture, Commerce, Health and Human Services, Energy, and Labor as well as from the EPA, Council on Environmental Quality (CEQ), Council of Economic Advisors, Office of Management and Budget (OMB),

Office of Policy Development,

(December 19, 1997). 607 Uncited author, (1984). ÒOMB Challenges EPA Plan to Regulate Biotechnology in Cabinet-level Draft.Ó Inside EPA (Weekly Report). Washington, DC. March 30, p. 1+10. 608 (49 FR 50856) at p. 50857. December 31, 1984. 609 (51 FR 23302). June 26, 19866 1 0 (49 FR 50856) at p. 50857. December 31, 1984.

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Office of Science and Technology Policy (OSTP), and the National Science Foundation (NSF).6 1 1 Jay Keyworth, ReaganÕs chief science advisor and the Director of OSTP, was assigned to serve as chairman.

Keyworth, in turn, delegated

the Working Group chair assignment to his deputy, Dr. Bernadine Healy Bulkley, who later would become the first woman director of NIH under Republican President George Bush.6 1 2 Dr. Healy, a Johns Hopkins cardiologist and self-described life-long Republican, was the life sciences specialist at OSTP.6 1 3

She has been variously described by

those who have worked with her as a Òself-confident, strong-willed, yet charming woman with an aggressive, forceful way of doing things.Ó6 1 4 As such, she was a driving factor in the negotiation of federal biotechnology policy. Healy worked under the premise that biotechnology was Ògood,Ó but that safety must be adequately assessed and that policy should be based on a process of balancing of risks and benefits.6 1 5 She was not 611

White House Memorandum dated April 30, 1984, from Martin (Marty) L. Smith, the Executive Secretary for the Working Group, to heads of all departments listed above, requesting names of appointed members. The first meeting was scheduled for May 9, 1984. MEJ personal archive, Folder: SS. Domestic Policy Council meetings were for principals only. William Gartland got an exception to go to those meetings because he was the director of the RAC. Interview with David T. Kingsbury, Ph.D. former Assistant Director, Biological, Behavioral, and Social Sciences, National Science Foundation. Washington, DC (December 15, 1997). 612 DISCovering Biography, (date of posting not given). ÒMore About Bernadine HealyÓ. GaleNet. Accessed April 30, 1999.. Although both surnames appear in official documents, for the sake of clarity I will use only the name Healy, by which she is more widely known. Born Bernadine Patricia Healy, she was divorced from surgeon George Bulkley in 1981 and married to Dr. Floyd Loop of Cleveland in 1985. 613 Ibid. 614 Comments compiled from interviews with Robert Cook-Deegan, John Cohrssen, Alvin Young, and David Kingsbury. Dr. Cook-Deegan was with the Congressional Office of Technology Assessment at the time. The other individuals are described in the text. 615 Healy, Bernadine, (1985). ÒBalancing Risks and BenefitsÓ in B i o t e c h n o l o g y :

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willing to accept that there were absolutely no risks involved in releasing rDNA into the environment.

According to her former chief

staffer, Alvin Young, Healy believed that the public was not going to accept the use of rDNA technology if there weren't regulatory oversight, especially when rDNA left the laboratory for the field.6 1 6 John J. Cohrssen served as legal counsel for the Working Group and also represented the Council on Environmental Quality (CEQ), which was part of the White House.6 1 7

Serving as the representative from the NSF

was David T. Kingsbury, a molecular biologist and director of the Naval Biosciences Laboratory at U.C.-Berkeley, who had just been asked by the White House to assume the position of Assistant Director of Biological, Behavioral, and Social Sciences at the NSF.6 1 8

Although USDAÕs Assistant

Secretary for Marketing and Inspection, C.W. McMillan, was officially on the Cabinet Council, he had delegated much of this responsibility to his Deputy, Karen Darling.

As mentioned in the previous chapter, Darling

brought Terry L. Medley, from the USDA Office of General Counsel, with her to many of those meetings. The White House Stand-off Against Congress and EPA

In January of 1984, a report was issued by the Congressional Office of Technology Assessment (OTA) entitled, ÒCommercial Biotechnology: Implications for Public Policy. S. Panem, Ed. Washington, DC. Brookings Institution. pp. 73-79. 616 Interview with Alvin L. Young, Ph.D. former Director, Office of Agricultural Biotechnology, USDA, and Executive Secretary of the ABRAC, USDA. Washington, DC (November 7, 1997). 617 Interview with John Cohrssen, J.D. former legal counsel, Cabinet Council Working Group on Biotechnology, Reagan Administration. Washington, DC (December 19, 1997). 618 Although he had not officially been sworn in until June of 1984, Kingsbury had begun to serve on the Working Group. Interview with David T. Kingsbury, Ph.D. former Assistant Director, Biological, Behavioral, and Social Sciences,

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An International Analysis.Ó

235

The report warned that Òalthough the

United States is currently the world leader in both basic science and commercial development of biotechnology, continuation of the initial preeminence of American companies in the commercialization of biotechnology is not assured.Ó6 1 9

For the Reagan Administration to

succeed in retaining a U.S. global economic lead in biotechnology, the thorny issue of domestic oversight, with its extreme diversity of opinions among policymakers, scientists, and the public, would have to be managed first.

The U.S. had already sent a delegation of agency

experts to Paris, France, in December, 1983 for a Safety and Regulation of Biotechnology Working Group set up by the Organisation for Economic Cooperation and Development (OECD).6 2 0

International reconciliation of

biotechnology policies was seen as essential.

A second international

meeting was scheduled for June, 1984, but the U.S. agencies still had not resolved their domestic policy differences.6 2 1

Which policy would they

put forth as the official U.S. position? The international negotiations regarding biotechnology policy, while beyond the scope of this account, were extremely important.

The

federal government had a limited pool of experts devoted to biotechnology policy.

The same people who were competing against

each other across agencies were forced to work together for the same

National Science Foundation. Washington, DC (December 15, 1997). 619 U.S. Congress and Office of Technology Assessment, (1984). C o m m e r c i a l Biotechnology: An International Analysis. U.S. Government Printing Office. Washington, DC. report. See p.iii. 620 The OECD members include industrialized nations of Western Europe, North America, Australia, New Zealand, and Japan. Tolin Archive, Box #2 Folder: OECD; miscellaneous papers. 621 ÒChronology of U.S. Participation, Safety and Regulation, Biotechnology,Ó Tolin Archive, Box #2; Folder: OECD papers.

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purpose when they represented the United States internationally.6 2 2 The White House clearly had incentive to resolve the issue. In February, 1984 the Gore Report was released.

Although the

report did not recognize a need for additional legislation, the recommendations had featured the extension of the authority of the EPA Òto include all deliberately released [rDNA] organisms not specifically identified as part of the legal obligation of another agency.Ó6 2 3

Another of the recommendations in the Gore Report was for

the formation of an interagency task force Òto review all proposals for deliberate releasesÓ specifying that the ÒEPA should take the initiative in organizing this panel.Ó6 2 4

(The Gore Report Recommendations are

reproduced in Appendix D.) Shortly after the May 16, 1984 decision by Judge John Sirica, which had given Jeremy Rifkin a partial victory against the NIH in FET v. Heckler,6 2 5 OSTP Director, Jay Keyworth, received a letter from four high ranking Members of the House Committee on Energy and Commerce. Representatives John Dingell, Henry Waxman, George Brown, and Al Gore, Jr. asked for a deliberation timetable and a copy of the charter for the Cabinet CouncilÕs Working Group on Biotechnology.

The four high

ranking Democrats expressed concern Òabout the need to develop a 622

Comparisons of membership lists of various biotechnology advisory panels and the U.S. delegations to the Organisation for Economic Cooperation and Development reveal many of the same names. 623 U.S. Congress, House of Representatives, Committee on Science and Technology, Subcommittee on Investigations and Oversight, (1984). The Environmental Implications of Genetic Engineering (The "Gore Report"). U.S. Government Printing Office. Washington, D. C. February. Staff Report. Serial V. See p.11. The Gore Report summarized the June 22, 1983 hearing. 624 Ibid. 625 This was the case filed by Rifkin on September 14, 1983 on behalf of his own and other public interest groups. Sirica, Judge John, (1984). Foundation on Economic Trends v. Heckler. Washington, DC. May 16. Memorandum and Order.

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suitable regulatory pathway for the products of biotechnology,Ó and disappointment that the Administration was not moving quickly enough in providing a mechanism for sorting out potential conflicting jurisdictional issues among the agencies.

The letter also registered a

complaint that the Òsubstantial groundwork that [had begun] at EPA, shortly after EPA asserted its jurisdiction under the Toxic Substances Control Act ... [appeared] to have slowed down considerably.Ó6 2 6 Congressional Democrats were pressuring for a larger role for the EPA in regulating the release of rDNA.

However, relationships between

Republican administrations and the EPA had traditionally been strained at best.

Furthermore, the strengthening of federal regulatory bodies in

general, least of all the EPA, was not among the Reagan AdministrationÕs goals.

At the same time, global harmonization of biotechnology policy

was imperative to American economic success, for example, in preventing patent infringement or in assuring international acceptance of American products of rDNA technology. There had no doubt been an uneasiness felt by the clearly probusiness Administration when in mid-1983 the EPA had initiated an attempt to establish itself as the lead agency in regulating the release of rDNA into the environment.6 2 7

Yet John Cohrssen recalled that

Monsanto had begun to pressure the EPA and the White House to be ready with regulatory protocols before the agricultural giant was ready with products.6 2 8

This surprising permutation, that industry w a n t e d the

D.D.C., C.A. No. 83-2714. 626 Letter to Jay Keyworth, dated May 24, 1984, from Congressmen Dingell, Brown, Waxman, and Gore. RAC document #1176. . 627 Hilts, Philip J., (1983). ÒEPA to Regulate Gene Engineering Firms.Ó Los Angeles Times. Los Angeles. August 10, p. I.19. 628 Interview with John Cohrssen, J.D. former legal counsel, Cabinet Council

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EPA to regulate release of rDNA, might make sense for several reasons. First, the big multinational corporations were already familiar with the ÒTSCA type approach.Ó

Second, this approach placed the burden of proof

on the EPA, not the applicant, to determine whether an unreasonable risk to health or the environment existed.6 2 9

Third, in a new technology

with uncertain risks, the holding of a permit or license issued by a federal agency essentially constitutes an insurance policy should anything later go awry.

Fourth, the added expense and delay that goes

with federal regulation can only be afforded by a few, usually large, companies, thus regulation serves as a barrier to entry, ensuring that only a few companies will be competing, each being guaranteed a larger market share.

One might also argue that regulating rDNA under TSCA

would have been good for industry, despite more cost and delay, because it would have assured the public that rDNA products were not so dangerous that they should be regulated any differently from chemicals.6 3 0 Certainly the smaller companies involved with biotechnology were not as supportive of EPAÕs approach as the multinationals.

During a

May 1, 1984 A-RAC meeting two representatives from APHIS expressed concern that ÒEPAÕs continuing activities regarding the regulation of genetically engineered organisms ... [was] creating much confusion and anxiety among biotechnology industries.Ó6 3 1

For example, excessive

Working Group on Biotechnology, Reagan Administration. Washington, DC (December 19, 1997). 629 TSCA is at 15 USC ¤¤2601-29; and 40 CFR 702. See also Krimsky, Sheldon, (1991). Biotechnics and Society: The Rise of Industrial Genetics. New York, Praeger. See pp.189, 190. 630 Edwards, Christopher G., (1983). ÒIndustry May Benefit From EPA Regulations (editorial).Ó B I O / T e c h n o l o g y. v. (November) p. 725. 631 Minutes of the A-RAC meeting, May 1, 1984, p.1. Tolin Archive, Box #1, Folder:

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regulation would have been prohibitively costly to the relatively poorly funded Land Grant University researchers, especially if researchers wanted to consider a small start-up company outside of the university.6 3 2

Members of A-RAC expressed a Òstrong sentiment ... that

development of cumbersome regulation of genetically engineered products [would] drive biotechnology industries out of the US....Ó6 3 3 In the private sector, Chief Executive Officer Daniel Adams of AGS was not pleased with EPAÕs declaration that the agency would regulate rDNA organisms as pesticides.

Adams was quoted in the journal

BIO/Technology as having said, ÒItÕs a pretty far-fetched extension of what a pesticide is.Ó6 3 4 Nor did the White House care for what they considered a narrow, process-based approach to oversight taken by the EPA on rDNA research and product development.

The OMB in particular was

concerned that regulation under TSCA Òcould have a serious effect on domestic and international trade.Ó6 3 5

The OMB was also concerned that

company financing would be channeled away from the particularly capital-intensive needs of the manufacturing and commercialization 6-4. 632 For example, in 1985, federal support for biotechnology research in Agriculture (ARS + CSRS) was only $72.5 million, compared with $1.8 b i l l i o n allocated for biotechnology research at the NIH. EPA received only $ 3.0 million for biotech research that year. In 1986 and 1987, NIH received 25 and 27 times USDAÕs allocation for biotech research. U.S. Congress and Office of Technology Assessment, (1988). New Developments in Biotechnology: US Investment in Biotechnology, Summary. U.S. Government Printing Office. Washington, D. C. July. Report. OTA-BA-401. 633 Minutes of the A-RAC meeting, May 1, 1984, p.1. Tolin Archive, Box #1, Folder: 6-4. 634 Powledge, Tabatha, (1984). ÒAGS Head Calls Frost Bug Ruling 'Farfetched'.Ó B I O / T e c h n o l o g y. v. (January) pp. 12-13. 635 Uncited author, (1984). ÒOMB Challenges EPA Plan to Regulate Biotechnology in Cabinet-level Draft.Ó Inside EPA (Weekly Report). Washington, DC. March 30, p. 1+10. See p.10.

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aspects of rDNA technology to fund safety testing and regulatory paperwork, thus sending negative signals to Wall Street.6 3 6

ÒWe thought

[EPA regulation] could kill the technology,Ó Cohrssen said candidly.6 3 7 Allowing new laws or regulations for biotechnology would have been tantamount to conceding that it was something special, new, and dangerous, thus requiring special, new, and immediate intervention from the federal government.

The White House wanted to encourage

the new industry because, for one thing, Japan was investing large sums for a technological leadership challenge.6 3 8

Meanwhile, the Congress

was putting on pressure to ensure safety and Jeremy Rifkin was threatening to litigate the technology out of existence.

To do nothing

would force the new technology into the existing regulatory system in a haphazard fashion as additional lawsuits were decided by judges trained in law, not science.6 3 9

The Administration sought to prevent a

patchwork of regulations across the country which might hamper the competitiveness of the young industry, thus pre-emption was another goal.

636

Legislating too early in the process would have locked the

Ibid. See p.10. Uncited author, (1984). ÒOMB Challenges EPA Plan to Regulate Biotechnology in Cabinet-level Draft.Ó Inside EPA (Weekly Report). Washington, DC. March 30, p. 1+10. 637 Interview with John Cohrssen, J.D. former legal counsel, Cabinet Council Working Group on Biotechnology, Reagan Administration. Washington, DC (December 19, 1997). 638 The Congressional Office of Technology Assessment concluded that ÒJapan will be the most serious competitor of the United States in the commercialization of biotechnology. ... and the Japanese Government has specified biotechnology as a national priority.Ó U.S. Congress and Office of Technology Assessment, (1984). Commercial Biotechnology: An International Analysis. U.S. Government Printing Office. Washington, DC. report. See p.21. 639 Unsigned, undated document from the office of Hon. George Brown entitled, ÒComments on: Proposal for a Coordinated Framework for Regulation of Biotechnology, Federal Register Notice of 12/31/84.Ó MEJ personal archive, Folder: SS.

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industry into regulations before it was known whether regulation would even be necessary.

Coordinating the Federal Framework The development of the Coordinated Framework involved many agencies and took over two years to finish.

A full account of its

development would take several volumes.

What I will emphasize here

are the aspects of the negotiation of this national policy which best elucidate the power and influence of the White House, and which are most relevant to agriculture.

One of these aspects, which has not been

detailed in other accounts, was an idea proposed by Working Group leader, Bernadine Healy. political implications.

It was a path not taken, but it had powerful

Another aspect was the insistence of the White

House that the USDA participate in the regulation of release of rDNA into the environment in order to limit any jurisdiction and power that the EPA might exert on the fledgling industry.

Other related events that

arose during this time period will be introduced to establish context, but will not be elaborated. A key limiting factor in the development of any approach to federal rDNA oversight was ReaganÕs strong commitment to Òno new regulations.Ó

The AdministrationÕs solution was to coordinate existing

statutes to cover oversight of rDNA.

The first step in coordinating the

federal oversight of biotechnology was to survey all agencies represented on the Cabinet Council Working Group on Biotechnology to determine the adequacy of existing authorities and the intended approach of each agency for using them for overseeing rDNA

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242

As discussed in Chapter Eight, Assistant Secretary

McMillan had requested these documents from the USDA agencies. The first meeting of the Cabinet Council Working Group on Biotechnology took place in the Spring of 1984, as the Executive Agencies were surveying their statutes and regulations and beginning to draft position statements and proposals for how a federal coordinating body for the oversight of rDNA should operate.

The closed

meeting of the Working Group on May 9, 1984, Òproduced considerable opposition to a heavy regulatory role by the GovernmentÓ as well as an expressed intent to stimulate rather than to impede the industry.6 4 0 The A-RAC was advised by member Gerald Still at its June 4 meeting that Jay Keyworth, ReaganÕs chief science advisor, had made it clear that cumbersome regulations, which might have a stifling effect on the growth of biotechnology industries, would not be tolerated.6 4 1 The Administration had two obvious options for where to place oversight for release of rDNA into the environment.

On the one hand

was the eager EPA, personna non grata in the eyes of the Administration, which had already been flexing its regulatory muscles. On the other was the apparently ambivalent USDA, which had so far failed to grab any regulatory turf.

The choice between the two was

easier than the chore of making it work.

640

Memo from Martin L. Smith, Deputy Assistant Director for Energy and Natural Resources, White House Office of Policy Development, to members of the Cabinet Council on Natural Resources and Environment Working Group on Biotechnology, dated April 30, 1984, announced date of meeting (MEJ personal archive, Folder: SS). Quoted report from Fishbein, Gershon W., ed., (1983). ÒBill Would Give EPA Authority over Biotechnology Products.Ó Genetic Engineering Letter. v. 3. (2) November 24. p. 1. See p.2. 641 Minutes of the A-RAC meeting, June 4, 1984, p.2. Tolin Archive, Box #1, Folder: 6-4.

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A Super-RAC Proposal

Over the summer of 1984, the Working Group chair, OSTPÕs Bernadine Healy, considered the options for a Coordinated Framework for oversight of rDNA.

She distributed her ideas to the Working Group

in a draft statement dated September 26, 1984.

The centerpiece of her

proposal was a ÒSuper-RACÓ structural concept, called the Biotechnology Advisory Board, which would have been Òa two-tiered advisory committee composed of 4 scientific subcommittees under a single coordinating parent committee.Ó6 4 2 As Healy envisioned it, the subcommittees would have consisted of the existing RAC, an expanded version of the A-RAC, plus two new subcommittees for Commercial Scale-up and Environmental Sciences. All of the subcommittees would be required to add public representation.

The parent committee (super-RAC) would have

consisted of the chairman and vice-chairman of each subcommittee, plus more public representation.

The parent committee would have

been responsible for reception and appropriate distribution of proposals to subcommittees for review, thus centralizing the oversight process. This RAC-type peer-review structure had worked well in academia and for the NIH.

Perhaps Healy, an academically oriented medical

researcher, assumed it would work as well in regulatory settings.

But

there was little enthusiasm for her complicated vision. Martin Smith, Deputy Assistant Director for Energy and Natural Resources at the White House Office of Policy Development and a member of the Working Group, in an October 22, 1984 memo suggested 642

ÒOptions for Coordinated Regulatory Framework,Ó a draft proposal written by Bernadine Healy Bulkley (BHB Draft) dated September 26, 1984. Tolin Archive, Box

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that HealyÕs Òsuper-RACÓ approach was less than optimal.

244 Smith

diplomatically wrote, ÒSuch an organization presents complicated organizational and legal questions.... [D]iscussions with staff at regulatory agencies raise questions on whether such a super RAC would provide timely and useful input for regulatory and commercial scale-up decisions.6 4 3 John Cohrssen, legal counsel to the Working Group, also had misgivings about the super-RAC structure.

He recalled,

Ò[Dr. Healy] really liked the super-RAC idea, but it was a bureaucratic nightmare. I knew it wasn't going to work. But she felt that it was important to say that there was going to be some central control, as a way of assuaging public concern. 6 4 4 Again on December 5, 1984 Smith, in alliance with Cohrssen, wrote another memo to the Working Group.

They suggested that the Healy

approach might experience Òconflicts with the Advisory Committee Act [and] Confidential Business Information data handling.Ó6 4 5 The two White House staffers submitted an alternate proposal for the scientific review mechanism of the Coordinated Framework, which for the first time suggested the name, Biotechnology Science Coordinating Committee (BSCC).

Although the functions of the BSCC under this proposal would

have been similar to those of the super-RAC, it would have been housed #1, Folder: 3-4. 643 Memo from Martin L. Smith to members of the Cabinet Council Biotechnology Working Group regarding suggested additions to HealyÕs proposal of September 26, dated October 22, 1984. Tolin Archive, Box #1, Folder: 3-4. 644 Interview with John Cohrssen, J.D. former legal counsel, Cabinet Council Working Group on Biotechnology, Reagan Administration. Washington, DC (December 19, 1997). 645 Memo from Martin Smith to Members of Cabinet Council Biotechnology Working Group, dated December 5, 1984, with draft of ÒScientific Review

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in the U.S. Public Health Service.

245

No need for public participation on the

parent committee was mentioned.6 4 6

Healy took the memo under

advisement. December 31, 1984

The first official draft of the ÒProposal for a Coordinated Framework for Regulation of Biotechnology; Notice for Public CommentÓ was released by the OSTP for public comment in the Dec. 31, 1984 Federal Register.6 4 7

Included in the notice was a regulatory matrix of

authorities for governing biotechnology.

Over seventeen pages of

statutes, regulations, guidelines, Executive Orders, and judicial decisions were included which covered a wide variety of policies having any possible relevance to biotechnology.

Entries covered a spectrum from

meat inspection and acceptable labeling practices to waste disposal, patenting, and workplace standards.

(A few of the measures relevant to

release of rDNA into the environment are outlined in Appendix F.)

The

December 31 notice also included draft statements of proposed policies from FDA, EPA, and USDA, plus a ÒScientific Advisory MechanismÓ for coordination of the agency policies.

It was clearly stated that the intent

of the Working Group was not to restrict the technology, but to ensure a regulatory policy that would Òenable a beneficial industry to proceed safely and efficiently.Ó 6 4 8

MechanismsÓ attached. Tolin Archive, Box #1, Folder: 3-4. 646 Ibid. 647 (49 FR 50856) December 31, 1984. Office of Science and Technology Policy, Executive Office of the President. (1984). ÒProposal for a Coordinated Framework for Regulation of Biotechnology; Notice for Public Comment.Ó Federal Register v. 49: 50856-50907. December 31. 648 Ibid. See p. 50856.

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Apparently confident that her plan could work, Healy centered the Scientific Advisory Mechanism on her super-RAC design, although she had modified it somewhat in the direction of the Smith/Cohrssen proposal.

The second tier of oversight would have consisted Òprincipally

of distinguished scientists selected by each of five federal agencies: EPA, FDA, USDA, NIH, and NSFÓ and would have been chartered within the Department of Health and Human Services.6 4 9

According to this version

of the Coordinated Framework, the NIH and NSF subcommittees would have reviewed biomedical and environmental basic research, respectively, while FDA, USDA, and EPA would have examined mainly commercial applications.

The second-tier Biotechnology Advisory

Board, instead of receiving and distributing all research proposals as in the original Healy plan, would have reviewed only a summary of each protocol, less any confidential business information, as forwarded by the individual agencies.

The parent board would also have Òevaluate[d]

review procedures set by the agency-based scientific advisory committees,Ó while providing a forum for public concerns.6 5 0 Although all of the various review boards were advisory, not regulatory, in nature, an interesting sentiment to ponder is that a twotiered system would allow the parent board to override decisions made by any one of the subcommitteesÕ review panels.

Most of the

Òdistinguished scientistsÓ on the super-RAC would have been representatives of agencies which were solidly in alignment with the Reagan AdministrationÕs schedule for the path of rDNA regulation. Healy apparently hoped that super-RAC oversight would manage

649 650

Ibid. See p. 50904. Ibid. See p. 50905.

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ÒinappropriateÓ scientific decisions from subsidiary science advisory panels in agencies favoring stiffer regulation.6 5 1

In the end, the

cumbersome two-tiered review system was emphatically rejected by public comment letters.6 5 2 FDA Statement The first draft of the Coordinated Framework demanded that all regulatory decisions regarding rDNA oversight be Òsolidly based on the best available science.Ó6 5 3

For its part in the document, the FDA stated

that all products would be regulated just as conventional products had been.

FDA concluded its short, uncomplicated statement of policy with

ÒRegulation by FDA must be based on the rational and scientific evaluation of products, and not on a priori assumptions about certain processes.Ó6 5 4

Note that such declarations would have effectively

eliminated obligation on the part of the Administration to consider any non-scientific public comments that it might receive, for example, the prospect of offending God or a request to honor the rights of species to remain genetically unviolated.

This restriction on what constitutes a

valid public argument against the AdministrationÕs plans no doubt helped to continue the channeling of any philosophical motivations of critics toward employing safety arguments, which could be presented statistically.

651

John Cohrssen, E-mail communication, May 13, 1999. (50 FR 47174) See p.47175. 653 (49 FR 50856) December 31, 1984 See p. 50904. The document is quite repetitive about insistence on science-based decisions. It states explicitly that Òthe importance of the highest caliber scientific advice to the decision-making process for oversight of biotechnology is u n d i s p u t e d (p.50858, emphasis added),Ó although it does not admit as important any advice of a non-scientific nature. 654 Ibid., See p.50880, emphasis added. 652

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EPA Statement EPAÕs portion of the notice focused on the application of its FIFRA and TSCA statutes.

It was highly detailed and informative and

specifically relevant to products of biotechnology, primarily microorganisms used commercially.

One controversial aspect of the EPA

statement constituted what appeared to be a process-based approach to regulation.

EPA distinguished between ÔnewÕ and Ônaturally occurringÕ

microorganisms by the Òmethods or processes by which they are produced and the level of human intervention involved.Ó6 5 5

Genetically

engineered products were defined as Ònew chemical substancesÓ and would be treated as any other Ònew chemical substancesÓ for purposes of regulatory oversight.6 5 6

The animosity that would develop over the

definition of the word ÔnewÕ as used by EPA was rivaled only by that over the definition of ÔbiotechnologyÕ. In spite of the decision to treat rDNA like any other new chemical, rDNA microbials would n o t be treated like other new chemical substances.

When it came to doing research with rDNA microbials on

small plots of less than ten acres, the EPA indicated in the 1984 statement that it was Òconsidering a changeÓ in its regulation, 40 CFR 172.3, to make official the mandatory notification of the agency before conducting small-scale releases of rDNA microorganisms for research purposes.6 5 7

This language making such notification a requirement was

already contained in EPAÕs previously published interim policy (see Chapter Eight).6 5 8 655

Each petitioner would have to submit a minimum list

Ibid. See p.50888 Ibid. See p.50881. 657 Ibid. See p.50885. 658 (49 FR 40659) October 17, 1984. The interim policy was intended to hold Ò[u]ntil EPA adopts a final approach to these pesticides, which [would then] include the 656

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of data requirements and wait up to 90 days for EPA to evaluate the notification before field research could commence.

EPA even hinted at

the possibility that they should consider experiments in greenhouses to be direct releases into the environment and under the jurisdiction of TSCA,6 5 9 further aggravating agricultural researchers.

Perhaps because

neither of these suggestions received much public support, it remained in EPAÕs best interest to hold to the interim policy, which had no sunset clause, and which would retain for the agency a measure of control over rDNA microbials. USDA Statement The USDAÕs statement of policy pronounced the adequacy of existing statutes and regulations, reaffirming the belief that rDNA products Òare not fundamentally different from products obtained from conventional technology.Ó6 6 0 The bulk of the statement focused on regulation of conventional research and development, and the effectiveness of proven regulatory processes against the introduction of foreign pests and agricultural pathogens.6 6 1

USDA repeatedly endorsed the RAC Guidelines as the

preferred oversight method for agricultural research.

No specific

requirements were made for rDNA product regulation, as were made by EPA, and no mention of deliberate release into the environment was made except to reiterate that all products would be regulated just as

opportunity for public comment.Ó See p.40660. Thus, the EPA was able to take control both of products and of research with genetically modified microbials used as pesticides immediately and without public interference. As of 1999, the interim policy still holds because EPA has not yet published a final rule. 659 (49 FR 50856) December 31, 1984 See p.50891. 660 Ibid. See p.50898. 661 Ibid.

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conventional products.

In this sense, the USDA statement was modeled

on the FDA statement.

Although the USDA claimed jurisdiction for ice-

nucleating microbes (such as Ice-Minus) in this 1984 document, it did not indicate h o w

such microbes would be regulated.6 6 2

Arriving at the completed 1984 Coordinated Framework proposal was Òa struggleÓ according to John Cohrssen.6 6 3

Although FDA stood

firmly on its intent to do nothing special for rDNA, and EPA had expressed what it wanted to do regarding microbial pesticide products, it appeared as though USDA was unprepared to manage the topic of biotechnology oversight. Disagreements among agencies had to be resolved.

As part of the

Cabinet Council Working Group, FDA Commissioner, Frank Young, was recruited to chair a Working Group meeting on November 14, 1984 to resolve issues among USDA, EPA, and FDA on policy statements. Young described the agency policy attitudes, ÒFDA, NIH, and NSF were usually in one camp.

Agriculture was swinging in the middle, and EPA was on

the other side.Ó

Young described part of USDA as frequently Òescaping

out into its own pro-regulatory realm,Ó although members of the agricultural research community would try to Òbring a sense of scienceÓ to the regulators.

Young supposed this was due to APHISÕ being staffed

primarily by nonscientists. fears,Ó he said.6 6 4

ÒThe imagined fears outstripped the real

YoungÕs characterization of USDA as Òswinging in the

middleÓ is probably due to the internal disagreement that was going on

662

Ibid. See p. 50902. Interview with John Cohrssen, J.D. former legal counsel, Cabinet Council Working Group on Biotechnology, Reagan Administration. Washington, DC (December 19, 1997). 664 Interview with Frank E. Young, P. D. M.D. former Commissioner, U.S. Food and Drug Administration. Washington, DC (December 18, 1997). 663

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during this same year (see Chapter Eight).

251

CSRS, staffed with research

administrators, was certainly in the same camp with NSF and NIH, but APHIS, as a regulatory agency, had perspectives more in common with EPA.

YoungÕs description of USDA scientistsÕ trying to bring their

regulators into line with the AdministrationÕs goals also speaks to the world view differences within the Department of Agriculture. It was not atypical for outstanding scientists, such as Young, to attribute the desire for restriction of rDNA technology to Òimagined fearsÓ that were due to a lack of understanding of science.

However,

such a conclusion dismisses or reduces the credibility of other possible reasons for wanting to regulate biotechnology, by lumping them all together with a less credible reason--fear of the unknown.

I suggest

that decisions regarding the best policy alternatives for rDNA had more to do with preexisting interests and beliefs (world view) than with lack of understanding or fear of science and technology.

1985: Ironing Out the Differences The first Coordinated Framework proposal of December 31, 1984 was a good start, but public comments showed that there was still a great deal of work to be done.6 6 5

Early in 1985, Bernadine Healy left the

White House to become the head of the Research Institute of the Cleveland Clinic Foundation.6 6 6

David Kingsbury from NSF, who had

been working with Healy on the coordination of rDNA oversight,

665

Tolin Archive, Box #31 contains a large number of public comments on the Coordinated Framework. 666 See biography of Healy at DISCovering Biography, (date of posting not given). ÒMore About Bernadine HealyÓ. GaleNet. Accessed April 30, 1999.

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inherited chairmanship of the Working Group.6 6 7

252 KingsburyÕs initiation

as the chair of the Cabinet Council Working Group on Biotechnology was an eye-opener. Ò[Dr. Healy] left and then I became chair. I thought everything was under control, but ... the first meeting that I chaired was [absolute] chaos. I mean the thing came apart. Bernadine had run this thing, but it just kind of erupted in [my] first meeting. We had nothing.6 6 8 The leadership styles of Healy and Kingsbury were radically different.

Healy, the Hopkins cardiologist, had had a more commanding

leadership style while Kingsbury, the U.C.-Berkeley molecular biologist, was depending upon his strength in consensus building.

Healy's

approach had included one-on-one negotiation of positions in advance of group meetings, which reduced the need for extended open debate.6 6 9 On the other hand, Kingsbury's large group approach toward a goal of general agreement left him open to an unpleasant surprise as high ranking politicos perceived a chance for their agencies to negotiate a bigger piece of the regulatory pie. Contributing to KingsburyÕs chairmanship difficulties, was that with HealyÕs departure, Òthe power of the White House had been dilutedÓ on the Council.6 7 0

He confided that it was also difficult for him to maintain

simultaneously two very different, very accountability-filled positions with contrasting goals.

667

Interview with David T. Kingsbury, Ph.D. former Assistant Director, Biological, Behavioral, and Social Sciences, National Science Foundation. Washington, DC (December 15, 1997). 668 Ibid. 669 David T. Kingsbury, E-mail communication, May 13, 1999. 670 Ibid.

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ÒI constantly felt schizophrenic in that period of time, because there I was at NSF where my job was to build world-class scientific research projects. On the other hand, I was spending part of my time trying to figure out how to interfere with the implementation of that science.6 7 1 Part of his ÒschizophreniaÓ may also have originated from his having been a U.C.-Berkeley Democrat transplanted to a Republican Administration in the middle of a highly politicized debate.

KingsburyÕs

response was to substitute scientific rigor for political positioning.

He

may have thought that sticking to the science would keep him above the politics Recruiting

APHIS

The Administration insisted on a coordinated national regulatory effort.

Despite USDAÕs declared preference for emulating the FDA in its

regulatory stance for products of rDNA (nothing new, nothing different) and for looking toward NIH for rDNA research Guidelines, in 1985 the Cabinet Council Working Group decided to ÒencourageÓ USDA to take jurisdiction over part of the rDNA release issue.

On July 19, 1985 the

Secretary of Agriculture John Block delegated all responsibility for oversight of agricultural rDNA research to the Assistant Secretary of Science and Education (the research division) and all responsibility for regulation of agricultural rDNA products to the Assistant Secretary for Marketing and Inspection.

Regulatory responsibility for rDNA products

was further delegated from the Assistant Secretary for Marketing and

671

Interview with David T. Kingsbury, Ph.D. former Assistant Director, Biological, Behavioral, and Social Sciences, National Science Foundation. Washington, DC (December 15, 1997).

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Inspection to the Administrator of APHIS.6 7 2

254

APHIS was the obvious

agency, because it already had several regulatory authorities which might be stretched to cover rDNA. Terry L. Medley, who had an interest in developing rDNA policy and who had been attending Cabinet Council Working Group meetings, was an obvious individual through whom to gain the DepartmentÕs participation in the coordination of federal oversight of biotechnology. Kingsbury, and others, worked with Medley to develop his understanding of molecular biology and the scientific principles behind rDNA technology.

Medley, who had acted only in a supporting role in

the development of the 1984 draft of the USDA statement, then began to take a more active role in the preparation of USDAÕs position for the final Coordinated Framework.

The difference in style and perspective

between the 1984 and 1986 versions of USDAÕs policy statements is striking.

For example, the 1984 version mimics the FDA attitude that

Ònothing is new; nothing will changeÓ while the 1986 version, with its accompanying documents, spells out more clearly what will be done, by whom, and how.

(See section, ÒThe Coordinated Framework of 1986,Ó

for more examples.) The powerful field of biotechnology had been introduced initially to the public amid fear.

Medley firmly believed that before this essential

technology could be utilized, and in order to facilitate its utilization, there would have to be a system in place to assure the public that it was safe.

He felt that as knowledge about rDNA grew and public

confidence was earned, regulations could be relaxed.

672

(50 FR 29367) July 19, 1985.

Medley was

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equally convinced that existing statutes were sufficient for oversight of rDNA releases. The Meeting in Philadelphia -A Turning Point6 7 3

One aspect of the debate that needed ironing out was the disagreements between groups of scientists about the safety of rDNA. The June 10-13, 1985 symposium in Philadelphia is important because it represents a crossroads in the path to political correction of biotechnology.

The meeting brought together ecologists and molecular

biologists who, in the past. had misunderstood each other and who had perhaps been working at cross purposes. In May of 1984, Representative Al Gore had written to the president of the American Society for Microbiology (ASM), Òformally requesting that ASM convene a national symposium to examine scientific issues involved in releasing genetically modified organisms into the environment.Ó6 7 4 the symposium.6 7 5

A-RAC and RAC collaborated with ASM to coordinate The purpose of the meeting was to identify means of

assessing the hazards of rDNA release so that national policy would not arise mainly from fear of speculative hazards. ASM News described the Philadelphia meeting as something of a Òblind dateÓ between microbiologists and ecologists, two groups who had very different tastes in biology.

673

ASM News reported that,

Proceedings of the meeting are in Halverson, Harlyn O., David Pramer and Marvin Rogul, Eds. (1985). Engineered Organisms in the Environment: Scientific I s s u e s Philadelphia, PA, American Society for Microbiology. 674 Letter from Congressman Al Gore, Jr. to Robert P. Williams, President of ASM, dated May 23, 1984. Tolin Archive, Box #1, Folder: 9-4. 675 Minutes of the A-RAC meeting, June 4, 1984, p.2. Tolin Archive, Box #1, Folder: 6-4.

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ÒMore than one microbiologist attending ... was struck by the seemingly obvious realization that ecologists address different but perfectly valid biological problems. Also striking was the well-received suggestion that, by asking such questions at the early stages of a biotechnology productÕs development, ecologists might make valuable contributions toward that productÕs eventual success in the environment--and the marketplace.6 7 6 According to Bernard Dixon (Harvard Medical School), who wrote a lay summary of the conference, the proceedings suggested ways in which the potential dangers in releasing rDNA organisms could be assessed.6 7 7

Although he noted some disagreements, DixonÕs

interpretation was that there were three points on which conference participants were in accord.

They were that,

Òregulatory standards ought to be applied to the product (the engineered organism) rather than the process (the genetic manipulation by which it was made).... that, in the early stages at least, regulation ought to proceed on a case-by-case basis.... [and that engineered organisms held] enormous promise ... for agricultural, medical, and environmental purposes.Ó6 7 8 Microbiologists discovered that many ecologists were not opposed to genetic engineering per se, they only wanted to be sure that the release of rDNA organisms was not going to disrupt delicate ecosystems.6 7 9 In

676

Fox, Jeffrey L., (1985). ÒFixed Up In Philadelphia: Genetic Engineers Meet With Ecologists.Ó ASM News. v. 51 (8) pp. 382-386. See p.384. 677 Dixon, Bernard, (1985). Engineered Organisms in the Environment: Scientific Issues (Lay Summary). Washington, DC, American Society for Microbiology. 678 Ibid. See p.15, 16. 679 For a summary of the position of the Ecological Society of America on release of rDNA organisms, see Tiedje, James M., Robert K. Colwell, Yaffa L. Grossman, Robert E. Hodson, et al., (1989). ÒThe Planned Introduction of Genetically Engineered Organisms: Ecological Considerations and Recommendations.Ó Ecology: A

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other words, ecologists were asking molecular biologists to consider a holistic, as well as a reductionist, approach to the uncertainties at hand. Given the EPAÕs quite natural deference to ecologists, once EPA began to assume regulatory authority for environmental release of rDNA organisms, ecologists began to play a more prominent role in the debates over safety.6 8 0

They wanted to ask impact questions up front,

not just examine consequences after the fact.

In a similar vein, if for

different reasons, Òasking the tough questions up frontÓ was exactly what Jeremy Rifkin was promoting.

Often proponents of release were

concerned that the questions asked by ecologists demanded more extensive answers than were known for a n y organisms.6 8 1

Opponents of

release had made liberal use of ecologistsÕ concerns, for example, the role that Pseudomonas species play in cloud formation which might have been disrupted by using Ice-Minus.6 8 2

However, when molecular

biologists and ecologists began to communicate and negotiate, Rifkin would lose some backing from ecologists.

Rifkin could not negotiate.

His plan required a complete surrender of the old way of doing things. This will be explored in the next chapter.

Publication of the Ecological Society of America. v. 70 (2) (April) pp. 297-315. 680 Krimsky, Sheldon, (1991). Biotechnics and Society: The Rise of Industrial G e n e t i c s. New York, Praeger. See p.135. 681 Personal communication with Sue A. Tolin, Ph.D. Professor of Plant Pathology, Physiology, and Weed Science, Former USDA representative to the NIH-RAC and OECD. Virginia Tech (various dates in 1998, 1999). 682 Odum, Eugene, (1985). ÒBiotechnology and the Biosphere.Ó S c i e n c e. v. 229 (Sept.27) p. 1338. Rhein, Reginald, Jr., (1985). ÒIce-Minus May End Killer Frosts-Rifkin also used And Stop the Rain.Ó Business Week. v. (November 25) p.42. climatic arguments for restricting the release of Ice-Minus during his attempt to hold up the approval of the AGS proposal at the June 1, 1984 RAC meeting. See minutes of that meeting, p.46.

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The Biotechnology Science Coordinating Committee (BSCC)

As introduced above, the idea for a BSCC had first been proposed by Martin Smith and John Cohrssen in a memo drafted by Smith on December 5, 1984 as an alternative to HealyÕs cumbersome ÒSuperRAC.Ó6 8 3

The new Biotechnology Working Group Chair, David Kingsbury,

liked the idea.

The BSCC was established on November 14, 1985 and

replaced HealyÕs jettisoned proposal of a super-RAC which would have contained lay people.6 8 4 Only high level agency officials sat on the BSCC, which circumvented broad public participation in the policy review process and simultaneously solved the problem of confidentiality regarding business information.

The original BSCC, chartered under the

Federal Coordinating Council for Science Engineering, and Technology (FCCSET), in the White House Office of Science and Technology Policy (OSTP), consisted of seven Assistant Secretary level appointees.

(See

Appendix G for a list of members.) The November 14, 1985 Federal Register notice also stated that USDA would establish a Committee on Biotechnology in Agriculture (CBA), under the co-jurisdiction of the Assistant Secretaries of Science and Education (research) and Marketing and Inspection (regulatory), which would assure that agricultural biotechnology decisions were based on the best available science.

NSF and EPA would establish similar agency-

based biotechnology committees.

On November 22, 1985, in

preparation for a transition to sharing oversight of rDNA with other 683

Memo from Martin Smith to members of the Cabinet Council Biotechnology Working Group, dated December 5, 1984. Tolin Archive, Box #1, Folder: 3-4. 684 (50 FR 47174). Office of Science and Technology Policy, Executive Office of the President. (1985). ÒCoordinated Framework for Regulating Biotechnology; Establishment of the Biotechnology Science Coordinating Committee.Ó F e d e r a l R e g i s t e r v. 50: 47174-47195. November 14.

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agencies, the NIH Guidelines were revised with an addition to Section III-A.

Upon notification to the RAC that a protocol was to be submitted

to another agency, the RAC could decide that the other agencyÕs review served the same purpose, thus the RAC would not need to get involved.6 8 5

The Coordinated Framework of 1986 The final rule on the Coordinated Framework for the Regulation of Biotechnology was signed by President Reagan on June 18 and published in the Federal Register on June 26, 1986.6 8 6

The 49-page

Federal Register document provides summary charts to designate which agency(ies) would have jurisdiction over each of the many types of rDNA research and products. provided in Appendix H.)

(A reconstruction of these charts is

Except for minor modifications, this

Coordinated Framework still serves, in 1999, as the official policy for federal oversight of biotechnology in the United States.

Here I will

address only a few of the points in the document related to release of rDNA into the environment. USDAÕs statement had changed considerably from the 1984 version. Although it retained the position that products of biotechnology Òwill not differ fundamentally from conventional products,Ó research and regulatory functions were now clearly divided.6 8 7

In addition, it

announced the establishment of an Office of Agricultural Biotechnology 685

(50 FR 48344) (51 FR 23302) See also Schneider, Keith, (1986). ÒBiotechnology Regulations are Signed by Reagan.Ó New York Times. New York. June 19, p. A25. 687 (51 FR 23302 See p.23336.) 6 8 8 U.S. Department of Agriculture, Animal and Plant Health Inspection Service. (1986). ÒPlant Pests; Introduction of Organisms and Products Altered or Produced Through Genetic Engineering; Proposed Rule and Notice of Public Hearings; Advanced Notice of Proposed Guidelines for 686

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(OAB) in the research division, and intent to establish an Agriculture Biotechnology Research Advisory Committee (ABRAC), a peer review advisory committee to parallel the RAC for agricultural rDNA research proposals.

The OAB would also be responsible for coordinating the

National Biological Impact Assessment Program (NBIAP) which would monitor biosafety and provide feedback information. Furthermore, APHIS published a companion document to the 1986 Coordinated Framework, which included changes to its part of the Code of Federal Regulations (7 CFR 330 and 340) to accommodate the Introduction of Organisms and Products Altered or Produced Through Genetic Engineering.6 8 8

A second companion document gave Advanced

Notice of Proposed Guidelines for Biotechnology Research, which were modeled on the NIH Guidelines, that would cover all USDA funded research.

Although the ABRAC worked on developing Guidelines for

field testing for research,6 8 9 those Guidelines have never been officially promulgated. The EPA had received many comments expressing concern that the agency was leaning toward a Òprocess basedÓ regulatory stance.

Commenters pointed out that ÒnewnessÓ should not

infer higher risk, nor did traditional production methods guarantee safety.

Although EPA did back away from attempting to regulate

greenhouse testing, other than to clarify its position, EPAÕs final statement changed little from the proposal of 1984.

The connection

Biotechnology Research.Ó Federal Register v. 51: 23351-23393. June 26. 689 Tolin, Sue A. and Anne K. Vidaver, (1989). ÒGuidelines and Regulations for Research with Genetically Modified Organisms: A View From Academe.Ó A n n u a l Review Phytopathology. v. 27 pp. 551-81. See p.567.

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between Ònew processÓ and Òtherefore regulatable articleÓ remained an open wound in the side of agricultural research. Product Versus Process

The goal of the Reagan Administration was to develop rDNA into a strong, competitive American technology.

The preferred mechanism for

achieving that goal was to minimize regulation.

As a compromise the

Administration had agreed upon a coordination of existing statutes and regulations in which the end use of a product would determine which agency would regulate it.

In other words, regulation would be product-

based, not process-based. The FDA had the least trouble with this concept.

FDA regulations

applied to all products meeting the statutory definitions of regulated items, regardless of the process used to produce them.6 9 0 New medicines had to go through an incredibly rigorous testing scheme, regardless of how they were produced.

ÒWe were able to say Ôproduct

not processÕ because we could capture it [anyway],Ó explained FDAÕs Eric Flamm.6 9 1

Except for the debatable case of live-virus vaccines, FDA was

not in the business of intentional release of rDNA into the environment. There was a finer line dividing product and process in the cases of EPA and USDA oversight.

For example, EPA wanted to use the same

statute to regulate rDNA as it did to regulate testing of chemicals, which suggests product-oriented regulation.

However, an interpretation of

690

Fanning, David W., (1988). Issues Raised by Biotechnology: A Keystone Biotechnology Discussion Paper. The Keystone Center. Keystone, CO. July 14. p.14. 691 Interview with Eric Flamm, Ph.D. Senior Policy Advisor to the Deputy Commissioner for Policy, U.S. Food and Drug Administration. Rockville, MD (December 3, 1997).

See

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TSCA that allows small plot exemptions for chemicals, while disallowing it for rDNA organisms, belies the EPAÕs position of Òproduct, not processÓ oriented regulation.6 9 2

Likewise, a later inconsistency was pointed out

between USDAÕs stated intention to be product oriented in its approach to rDNA oversight and the decision that APHIS would Òdefine all recombinant DNA species as exotic organisms, which make them Ônew to ... the United StatesÕ and subject to review.Ó6 9 3

Forced by the

Administration to promulgate Òno new regulations,Ó it was the only way to make existing rules Òfit.Ó The Coordinated Framework was a product-based approach to rDNA policy.

Product oriented regulation is conservative.

federal government has always regulated industry.

It is the way the The reasoning that

science had always monitored itself, therefore, no new regulations were needed, was conservative.

The need to preserve American

competitiveness was so important that unproven hazards were downplayed because benefits to the economy were so great. In contrast, the European Economic Community (later the European Union), perhaps owing to some influence by its more powerful Green parties, chose a different approach from the U.S.

The European CouncilÕs

Directive 90/200 set up a centralized, process-based framework consistent with which every member country had to develop its own laws for oversight of release into the environment.6 9 4

ÒThey could not

use their existing laws and structures like we did,Ó said Terry 692

Fanning, David W., (1988). Issues Raised by Biotechnology: A Keystone Biotechnology Discussion Paper. The Keystone Center. Keystone, CO. July 14. See p.12. 693 Ibid. See p.9. 694 For the text of Directive 90/220/EEC, see the Belgian Biosafety Server at http://biosafety.ihe.be/GB/Dir.Eur.GB/Del.Rel./90.220/TC.html Last accessed on

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.6 9 5 In the short term, the Òno new regulationsÓ approach benefited American leadership in rDNA research.

But it had a down side, which

ironically is economic in nature.

The goal of global harmonization of

oversight has not been reached.

In fact, so different is the U.S. approach

to oversight from many of the other developed countries in the Organisation for Economic Cooperation and Development (OECD) that today, many Europeans spurn and distrust products from American agricultural biotechnology giants like Monsanto.6 9 6 One APHIS employee noted recently, ÒWhen you consider international trade, if people donÕt trust the technology, and your regulations are not stringent, they donÕt trust you to have been careful enough. In the Ô80s we couldnÕt get the [research done]. Now itÕs done and we canÕt sell the stuff.Ó6 9 7 Elizabeth Milewski, who in 1986 had moved from the NIH Office of Recombinant DNA Activities to the EPAÕs Office of Pesticides and Toxic Substances, explained the Òproduct versus processÓ distinction in terms of a Òreductionist versus holisticÓ outlook on the impact of the technology. ÒThere were the scientists who looked at this technology and said, ÔWe're all made of interchangeable parts and because this is what life does anyway--it moves parts around--why spend a lot of money regulating it?Õ This is a reductionist approach. October 6, 1999. 695 Interview with Terry L. Medley, J.D. former Director of USDA-BBEP and Administrator of APHIS, USDA. Washington, DC (December 11, 1997). 696 Kilman, Scott and Helene Cooper, (1999). ÒCrop Blight: Monsanto Falls Flat Trying to Sell Europe on Bioengineered Food.Ó Wall Street Journal. . May 11, p. A1. 697 Interview #2 with Shirley Ingebritsen, Senior Regulatory Specialist, APHIS, USDA. Washington, DC (October 2, 1997).

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ÒThen there are those who said, ÔWell, it may be true that a great percentage of the parts are interchangeable, but for life there is always a uniqueness that characterizes it.Õ ... They thought that in moving one gene one could not predict its performance in its new genome because the genome had been changed. It was more complex than just adding one gene. This was a more holistic position.6 9 8 With this analogy, Milewski has hit upon a key characteristic of the rDNA controversy:

OneÕs customary approach to understanding nature,

i.e. general propensity for a reductionist or holistic viewpoint,

plays a

principal role in determining oneÕs position in a science controversy, regardless of whether or not one understands the details of the science involved.

This idea will be addressed again in my concluding chapter.

The Òproduct versus processÓ issue defined the rDNA controversy for the rest of the decade.

Once regulation became a foregone conclusion,

proponents of rDNA technology wanted their products to be regulated like any other products.

Critics insisted that the rDNA process was so

new and different that it had to be regulated separately. The Hierarchy Effect

One explanation for the AdministrationÕs success in negotiating a Òproduct not processÓ approach to rDNA oversight, aside from having a conservative president and Senate majority, has to do with what I call the Òhierarchy effect.Ó6 9 9

When examining the civil service rank of the

biotechnology specialists within agencies which were in alignment with 698

Interview with Elizabeth Milewski, Ph.D. formerly on staff at NIH-ORDA, presently Special Assistant for Biotechnology, EPA. Washington, DC (December 5, 1997). 699 I thank Dr. Frank Young, former FDA Commissioner, for his insight into this hierarchy concept.

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the Reagan philosophy of minimal oversight, we find that all of the biotechnology specialists from these agencies (FDA Commissioner Frank Young, ORDA Director William Gartland, and NSF Assistant Director, David Kingsbury) worked in close hierarchical proximity to the highest ranking officer in that department.

These high ranking rDNA policy

specialists had daily access to the principals who made the final decisions for the agencies as well as access to many more resources than did their counterparts in EPA and USDA. The personnel in EPA and USDA (primarily APHIS) who were actually involved in the details of rDNA policy ranked far lower in their agencies.

It may have taken days or even weeks for them to get

appointments with a top administrator--who would have been a conservative presidential appointee--to present their arguments.

So far

as resources went, they were essentially on their own. To illustrate the powerful difference in resource mobilization ability, former FDA Commissioner, Frank Young, put it like this: ÒWell, [it had to do with] the ability to mobilize the entire agency. If I had to deal with something in biotechnology, I could call up the head of CBER and say, ÔIÕd like to have 10 scientists working on this policy. I want them to stop whatever else they are doing and for the next three weeks, I want this done. Any problems with that?Õ7 0 0 Recall that the people who were negotiating U.S. domestic rDNA policy were the same ones working toward harmonization of rDNA policy on an international level.

The Òhierarchy effectÓ was present in

the international delegation as well, as EPA and APHIS, more aligned

700

Interview with Frank E. Young, P. D. M.D. former Commissioner, U.S. Food and Drug Administration. Washington, DC (December 18, 1997).

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with the European perspective on rDNA release, worked at cross purposes with the rest of the U.S. delegation.7 0 1

Concurrent International Affairs Although space does not permit me to go into great detail about the negotiation of U.S. international rDNA policy, it was so intertwined with the domestic controversy that it is essential to sketch some aspects of it here. In 1985, at one of the Organisation for Economic Cooperation and Development (OECD) meetings about release of rDNA into the environment, the domestic policy dispute spilled over into international affairs.

John Cohrssen, who had been on the Cabinet Council

Biotechnology Working Group, which was putting together the Coordinated Framework at the time, recalled, ÒI was told that there were almost as many different opinions as there were delegates at the table. It was that polarized... and it became heated.7 0 2 According to Cohrssen, when the delegation returned from that meeting, two investigators from Congressman John DingellÕs Oversight and Investigations Subcommittee (of the House Energy and Commerce Committee) began an investigation of the incident.

The last thing the

Administration wanted was interference from the House Democrats. Cohrssen recalled. ÒBernadine [Healy, the chair of the Working Group] said to me, ÔWe've got a problem. We need to do 701

Interviews with John Cohrrsen, David Kingsbury, Terry Medley, Elizabeth Milewski, and Frank Young all indicated that there was such tension within the international delegation. 702 Interview with John Cohrssen, J.D. former legal counsel, Cabinet Council Working Group on Biotechnology, Reagan Administration. Washington, DC (December 19, 1997).

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something...to manage this.Õ It was right about the time I started working for her in OSTP. That was the summer of 1 9 8 5 .7 0 3 The international incident compelled the Administration to insert reference to OECD into the final draft of the Coordinated Framework. Language about harmonization of international policy to reduce barriers to international trade was added to the June 26, 1986 version. Overruling any splinter group views, the Administration reiterated the official consensus of the Executive Branch: ÒThere is no scientific basis for specific legislation for the implementation of rDNA technology and applications.Ó7 0 4

This message, which language came from the OECD

counsel statement published in the ÒBlue Book,Ó7 0 5 served to reinforce the Reagan AdministrationÕs intent to protect American economic interests abroad, as well as its insistence upon a unified agenda at home.

Effects of Coordinated Framework Did the Coordinated Framework end the rDNA policy controversy? Not at all.

Although it served to divide the regulatory spoils among the

AdministrationÕs preferred agencies, this policy, Òsolidly based in science,Ó7 0 6 left the technology controversy without closure because it never addressed the underlying social issues.

703

In fact, public comments

Ibid. (51 FR 23302), at p.23308. 705 Organisation for Economic Co-operation and Development, (1986). R e c o m b i n a n t DNA Safety Considerations: Safety considerations for industrial, agricultural, and environmental applications of organisms derived by recombinant DNA t e c h n i q u e s. OECD. Paris, France. 1986. Report of the Ad hoc Group on Safety and Regulations in Biotechnology. See. p.6. 706 Language used in Coordinated Framework. (51 FR 23302) June 26, 1986. 704

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that were not related to safety, functionality, or environmental impact of rDNA activities were specifically excluded as irrelevant, as mentioned earlier for example, by the FDA in considering the approval of chymosin preparation.7 0 7

The possibility that rDNA technology would not be

pursued at all was never an option. Like the establishment of the NIH Guidelines a decade before, one might have expected the Coordinated Framework to usher in a period of quasi-quiescence for the Release Era, when research could continue with relatively little public attention.

To some extent that did happen,

because the Coordinated Framework defined to which agency a researcher or developer should refer for guidance, but there was a long lag period.

Krimsky believed that the Coordinated Framework might

end congressional activity on the subject of rDNA.7 0 8

However, efforts

continued in the Congress until 1990, when the Omnibus Biotechnology Act, the last attempt at regulating rDNA during the Release Era, was proposed in the House.

This legislation, and those who produced it, will

be described in Chapter Eleven. Nor was the agricultural community content.

Laws like the Plant

Pest Act of 1957 had to be stretched to great length to accommodate rDNA oversight.

In order to modify existing statutes to cover the

planned introduction of rDNA into the environment, USDA lawyers had to combine the concept of ÒmovementÓ from one location to another (for example, from one laboratory to another) and the assumption that the 707

(55 FR 10932) March 23, 1990. Krimsky, Sheldon, (1987). ÒGene Splicing Enters the Environment: The SocioHistorical Context of the Debate Over Deliberate ReleaseÓ in Application of Biotechnology: Environmental and Policy Issues. J. R. Fowle, III, Ed. Boulder, CO. Westview Press for the American Association for the Advancement of Science. pp. 27-53. See p.47. 708

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introduction of a single gene might turn it into a plant pest.

The Plant

Protection and Quarantine section of APHIS, issues permits for movement of articles that are or might be considered plant pests.

In

order for APHIS to regulate rDNA without legislative action, its authority had to include movement from a laboratory to the field, and its definition of Òregulatable articleÓ had to include rDNA as a potential plant pest.

This artful interpretation of statutes satisfied APHIS, but

left the CSRS appalled. Although it had the positive effect of designating a path by which agriculture could get on with field testing, possibly the worst effect of the Coordinated Framework on the agricultural community came not during the Release Era, but is only now being felt during the Global Era of the rDNA debate.

ReaganÕs focus on international competitiveness to

the exclusion of meaningful efforts to harmonize with international opinion on regulation of rDNA release issues has had a profound lag effect on todayÕs European market for products of American agricultural biotechnology.

Summary An entire volume would be needed to examine all aspects of the development of the Coordinated Framework for the Regulation of Biotechnology and the chronologically coincidental international activities.

Even those aspects relevant only to the release of rDNA into

the environment would require lengthy treatment.

For my purpose, I

have attempted to focus my research on the concept behind the Coordinated Framework and the political power exhibited by the Reagan Administration in establishing such a regulatory device.

The insistence

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of a powerful Republican president on Òno new regulationsÓ to restrict industry, backed by a Republican Senate majority in the Congress, almost guaranteed that a conservative, reductionist approach to rDNA oversight (as defined by Milewski, above) would be a difficult policy path for holistic opponents to correct. An examination of the Reagan AdministrationÕs takeover of biotechnology oversight represents a unique opportunity to study the role of science in politics--and vice versa.

Attempts by personnel at

EPA and APHIS to strengthen public regulation were restrained in favor of an approach that Reagan science advisor George (Jay) Keyworth called Òan exercise in priority setting and decision making ... carried out in the context of other national policies....Ó7 0 9 Although the Administration succeeded in most of its efforts to reduce restrictions on industry, its VICTORY was not complete.

EPAÕs

interim policy for oversight of all rDNA releases, including nonexemption for small research plots, is still in effect.

Although the

White House was able to pressure the USDA into agreeing to take some responsibility away from the EPA by encouraging a turf war between the agencies, in MedleyÕs hands APHISÕ regulatory intent began to look a bit more like EPAÕs than the Administration would have liked because it had similar regulatory triggers (i.e., the process of rDNA modification). Thus the conservative Administration failed to keep the liberal components of the Executive Branch completely under its control.

A

slight political correction in the conservative path of rDNA policy 709

Testimony in U.S. Congress, House of Representatives, Committee on Science and Technology, (1982). U.S. Science and Technology Under Budget Stress. U.S. Government Printing Office. Washington, DC. December 10, 1981 and February 2,3,4, 1982. Hearings. 97/118. See p.6.

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resulted as more liberal perspectives were able to take hold, despite the Òhierarchy effectÓ that was against them.

The American role in the

Global Era of the rDNA controversy, in which we are immersed today, gestated in this atmosphere of inequality of political power among federal rDNA specialists during the Reagan Administrations. In the next chapter, I will examine the position and strategies of the most radical of all rDNA critics--Jeremy Rifkin, founder and president of the Foundation on Economic Trends, the Greenhouse Crisis Foundation, the Beyond Beef Coalition, and the Pure Food Campaign, all of Washington, DC.

CHAPTER TEN: JEREMY RIFKIN - A GREENER WORLD VIEW Ò[Nothing should] be condemned without understanding it, without learning it, without even hearing it.Ó - Galileo, 1615.7 1 0

Introduction Jeremy Rifkin was and still is the primary agitator against the development of rDNA technology.

Because his position and tactics have

been so extreme, the biotechnology industry has on occasion labeled him as a scientifically untrained leader of any and all opposition, in an attempt to reduce the credibility of all critics.7 1 1

However, this may no

longer be the most advantageous strategy, given the current global climate for rDNA agricultural products.7 1 2

A better approach might be

to attempt to understand the underpinnings of his anti-technology

710

I was unable to locate the original source of this Galileo quote. It is cited from Lakatos, Imre, (1978). The Methodology of Scientific Research Programmes. New York, Cambridge University Press., at p.169. The exact quotation used by Lakatos, with notation preserved, was Ò[nothing] be condemned without understanding it, without learning it, without even hearing it.Ó The quote was footnoted simply, ÒGalileo, 1615.Ó 711 Plein, L. Christopher and David J. Webber, (1989). ÒBiotechnology and Agriculture in the Congressional Policy ArenaÓ in The Political Economy of US Agriculture: Challenges for the 1990's. C. S. Cramer, Ed. Washington, DC. National Center for Food and Agricultural Policy, Resources for the Future. pp. 179-201., at p.189. PleinÕs claim has been supported by many conversations I have had with scientists and policy analysts at biotechnology conferences I attended during the early 1990s. 712 Spearheaded by Green party activists, the European community has spurned American food products of rDNA origin. See Claude, Patrice, (1999). Ò'Charles le Bio' Contre ' Tony le Transgenique'.Ó Le Monde. Paris. June 3, p. 1.; Kilman, Scott and Helene Cooper, (1999). ÒCrop Blight: Monsanto Falls Flat Trying to Sell Europe on Bioengineered Food.Ó Wall Street Journal. . May 11, p. A1.; and Associated Press, (1999). ÒGenetic Engineering is Focus of Summit.Ó Sarasota Herald Tribune. Sarasota, FL. February 20,

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A study of RifkinÕs world view sheds light on his use of the

rDNA technology debate as a weapon in his campaign for social justice. Jeremy Rifkin has played such a prominent role in the rDNA controversy that his philosophy is worth singling out for review.

Within

their own context, his radical views are reasonable and even predictable.

He shares his ideology, if not his tactics, with others who

embrace a philosophy of social justice and green environmentalism. Although Rifkin has played an important role in biotechnology policy in general, in this chapter I will focus primarily on his interactions with the agricultural community during the mid-1980s.

RifkinÕs World View As expressed openly in his many books, RifkinÕs philosophy, which is compatible with a Green political party philosophy, includes environmental conservation, an appreciation for holistic approaches to knowledge, and a liberal idealism that treats all of GodÕs creation, human and non-human, with respect.

The antithesis of his philosophy

is what has been called Òmechanistic reductionism.Ó7 1 3

Rifkin explained

in a 1987 televised debate with USDA Chief Scientist John Fulkerson that Òmechanistic reductionismÓ undermines the sacredness of life. Rifkin also expressed his belief that science should be used to enhance society's wellbeing and its ability to build relationships with the

713

In brief, mechanistic reductionism refers to the belief that by studying the parts of a phenomenon individually, one can understand the whole. This concept has worked well for physics. However, opponents of mechanistic reductionism object to the philosophical reduction of a living thing to a mere collection of its parts. For a more in-depth discussion on this topic, see the Epilogue in Shiva, Vandana and Ingunn Moser, Eds. (1995). Biopolitics: A Feminist and Ecological Reader on Biotechnology London, Zed Books.

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ecosystem instead of being used to control, dominate, and exploit n a t u r e .7 1 4 Aside from RifkinÕs concerns about the dignity of mankind, the threat to the integrity of species, and endangerment, however small, to the environment that rDNA products might present, there is a large economic component to his cause.

In a nutshell, Rifkin struggles against

the continued existence of multinational corporations that thrive on the expansion of consumerism.

This focus, he says, helps to perpetuate the

transformation of natureÕs resources into waste products.7 1 5 RifkinÕs vendetta is against wealthy corporate stockholders who, by condoning the exploitation of both the environment and working classes in order to increase profits at any cost, are disregarding GodÕs plan and the sanctity of nature.

These convictions are expressed in almost every

book he has written since before he became aware of rDNA. In one of his earliest books, Common Sense II, Rifkin paraphrased Thomas PaineÕs famous 1776 diatribe by substituting the villainous multinationals for the villainous British aristocracy.7 1 6

In the period

1967 through 1970, Rifkin openly opposed the war in Vietnam by sponsoring a major rally in New York and by staging a mock war-crimes trial in Washington.7 1 7

Before biotechnology came to his attention,

Rifkin spent the major portion of the 1970s pursuing the activities of 714

Crossfire with Tom Braden and Bob Novak (1987). John Fulkerson, USDA, versus Jeremy Rifkin, FET. CNN-TV. April 20. Washington, D.C. 715 Rifkin, Jeremy and with Ted Howard, (1980). Entropy: A New World View. New York, Viking. 716 Rifkin, Jeremy, (1975). Common Sense II: The Case Against Corporate Tyranny. New York, Bantam Books, Inc.; Adkins, Nelson F., Ed. (1953). Thomas Paine: Common Sense and Other Political Writings. American Heritage Series. New York, Liberal Arts Press. 717 Boffey, Philip M., (1984). ÒAn Activist Takes on Genetic Engineering.Ó N e w York Times. New York. April 11, p. B10.

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his PeopleÕs Bicentennial Commission, an organization described by one Newsweek reporter as Òa brash band of low-combustion incendiariesÓ that opposed the commercialization of the bicentennial by multinational corporations.7 1 8

When still in his twenties, Rifkin advocated a political

revolution Òto challenge existing institutions and those in powerÓ by using the American Bicentennial celebration Òto create a mass revolutionary consciousness in tune with the revolutionary legacy of 1776.Ó7 1 9

Rifkin listed twelve tenets for his new society, from which he

has not wavered in over a quarter of a century of writings. These twelve points are: 1 . Human values are placed above property values. 2 . Personal interests can be identified with the collective interest. 3 . Health care is a human right rather than a marketplace commodity going to the highest bidder. 4 . Technology is made to serve rather than to exploit man and the environment. 5 . Production for profit and war is replaced by production for human needs and peace. 6 . Control of the economy is taken from the very rich and returned to the worker and consumer. 7 . Economic social, racial, and sexual barriers give way to equality and opportunity for all. 8 . The human aspirations we seek to fulfill at home guide our relations with other peoples of the world. 9 . People regain control over decisions and institutions that affect their lives. 1 0 . Orthodoxy is challenged; creativity is encouraged.

718

Matthews, Tom and Jane Whitmore, (1975). ÒUp-To-The-Minutemen.Ó N e w s w e e k. v. (May 19, 1975) p. 29., at p.29. See also Howard, Ted, (1976). The P.B.C.: A History. Washington, DC, The People's Bicentennial Commission. 719 Rifkin, Jeremy and John Rossin, (1973). How to Commit Revolution American S t y l e. Secaucus, New Jersey, Lyle Stuart, Inc., at p.136.

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1 1 . The search for transcendence and ultimate awareness of ourselves and our environment is nourished as the highest aspiration of mankind. 1 2 . The proposition prevails that Òall men are created equal, that they are endowed by their Creator with certain inalienable rights, that among these are Life, Liberty, and the Pursuit of Happiness.Ó7 2 0 When the bicentennial celebration was over, Rifkin needed a new anti-corporate strategy for his group, which was renamed the PeopleÕs Business Commission.

By his own admission, Rifkin Òstumbled into

biotechnology almost by accident after a long career of activism.Ó7 2 1 Biotech was big, expensive, and potentially frightening.

As such it

became RifkinÕs primary weapon against the multinational corporations and the traditional political and economic system that supported them. Before RifkinÕs name became familiar to the agricultural community, he and a group of followers disrupted a 1977 National Academy of Sciences forum chanting, ÒWe will not be cloned,Ó while displaying banners that said, ÒDonÕt tread on my genes.Ó7 2 2

The same year, he assisted

Pentecostal minister Ted Howard, in publishing Who Should Play God? The Artificial Creation of Life and What it Means for the Future of the Human Race, in which the coauthors claimed that scientists and corporations were involved in Òincestuous tiesÓ to seduce consumers

720

Text is from Rifkin, Jeremy and John Rossin, (1973). How to Commit Revolution American Style. Secaucus, New Jersey, Lyle Stuart, Inc. See pp. 143-144. The term ÒtenetsÓ is my own. 721 Boffey, Philip M., (1984). ÒAn Activist Takes on Genetic Engineering.Ó N e w York Times. New York. April 11, p. B10. 722 Current Biography Yearbook 1986. (1987). Moritz, Charles, ed. . H.W.Wilson Co. New York. , at p.469.

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into accepting genetic engineering so the companies could reap big profits.7 2 3 An analysis of his many books reveals a carefully thought out master plan.

According to Rifkin, the greed of the corporate rich and their

general lack of respect for GodÕs creation, of which we are a part, are seen as the worldÕs greatest problems.

RifkinÕs solution is to

redistribute that wealth and return power to the people so that together they can conserve the environment and the rights of all living creatures. His concern lies with the working classes, not with the interests of stockholders in corporate America.

He recognizes that corporations will

not hand over resources and concludes that they must be taken by force.

Rifkin targets biotechnology because he knows it is such a

powerful technology that, in the hands of the U.S. based multinationals, it will prevent his idealistic goal of a sharing, caring, empathetic world order from ever being.

Biotechnology will assist corporate villains in

accelerating their exploitation of nature. Rifkin believes that rDNA is a threatening weapon against nature and the working classes.

If a technology is viewed as a weapon, whoever

controls the technology--or the policy that regulates it--is likely to hold a strong advantage over political opponents.

If one can not afford the

technology, if one is denied access to its benefits, or if one is simply philosophically opposed to it for whatever reason, it is in that personÕs best interest to prevent others from controlling it.

The use of a n y

available weapon against multinational corporations to prevent his enemies from gaining control of a threatening weapon is internally 723

Howard, Ted and Jeremy Rifkin, (1977). Who Should Play God? The Artificial Creation of Life and What it Means for the Future of the Human Race. New York,

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consistent with RifkinÕs beliefs and goals, and is therefore, within that context, reasonable. In 1984, the year he began using the U.S. judiciary system against biotechnology,7 2 4 Rifkin published Algeny, in which he depicted genetic engineering as the Ònew evolutionary theory,Ó which was merely an extension of DarwinÕs socially biased theory and a reflection of the industrial state of mind.7 2 5

The combination of genetic engineering and

computer science is a particular threat to RifkinÕs envisioned ideal social community.7 2 6

DNA is the essence of lifeÕs information. Genetic

sequences can be reduced into bits of information stored in computers. Rifkin claims that multinational corporations, which are already capable of existing only as data in cyberspace, exhibit allegiance to no particular geographic location or ecosystem, only to wealthy stockholders.

They

can easily pack up their computers and move to a new location after depleting resources at a previous one.7 2 7 over information.

The key to power is control

Therefore, Rifkin warns that those in control of

biotechnology will control the rest of us.

Ostensibly, he attempts to

keep the industry from rushing ahead with the technology before ethical considerations can catch up.

In actuality, he attempts to keep

the multinationals from rushing ahead with control of the working class before the working class can catch up.

Delacorte Press. See p.196. 724 See FET v. Heckler in Chapter Eight. 725 Rifkin, Jeremy, (1983). A l g e n y. New York, Viking Press. 726 Rifkin, Jeremy, (1998). The Biotech Century: Harnessing Remaking the World. New York, Tarcher/Putnam., at p.190 Jeremy, (1989). Time Wars: The Primary Conflict in Human Simon & Schuster. 727 Rifkin, Jeremy, ed. (1991). Biosphere Politics: A Cultural Middle Ages to the New Age New York, Crown.

the Gene and See also Rifkin, History. New York, Odyssey from the

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Unlike the Executive Branch of the U.S. Government, which took almost two years to design and implement the Coordinated Framework, Rifkin and his small staff at the Foundation on Economic Trends had no need to worry about being able to keep up with the changing demands of a rapidly developing technology.7 2 8 instantly to any new events. established institutions.

Rifkin could respond almost

He operated both inside and outside of

For example, his strategies included boycotts

and demonstrations as well as civil prosecutions.

His publicity stunts

drew attention and garnered public support for his cause.

His mastery

of the sound bite is renowned, but litigation is where Rifkin has excelled. It has frequently been pointed out that Rifkin has had no formal scientific training.7 2 9

Because of his lack of scientific training and his

sensational tactics and prophecies of doom, RifkinÕs ideas are often discounted as an irrational vendetta against biotechnology. Nevertheless, within his own world view context, and considering his goals, RifkinÕs fundamental principles and strategies are completely reasonable and consistent.7 3 0

728

For example, RifkinÕs transition from the

In 1989, RifkinÕs staff consisted of only a handful of people, according to political scientist, Christopher Plein, who visited the FET. (Interview with L. Christopher Plein, Ph.D. Assistant Professor of Public Administration, West Virginia University (October 28, 1994).) This is remarkable, considering Rifkin runs several organizations out of the same Washington, DC, office. For example, the Foundation on Economic Trends, the Pure Food Campaign, the Greenhouse Crisis Foundation, and the Beyond Beef Coalition all have the same address at 1130 Seventeenth Street, N.W., Washington, DC, 20036. 729 Rifkin has an undergraduate background in economics (Wharton) and a masterÕs degree in international deplomacy (Tufts). 730 For a discussion of world view (a way of looking at reality) and rationality, see Kearney, Michael, (1984). World View. Novato, CA, Chandler and Sharp Publishers, Inc.

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use of Òredneck powerÓ7 3 1 to environmentalism in his battle against multinationals is a classic example of what rural sociologist Frederick Buttel presented as a substitution of environmental justice for social justice by Ògreen forces.Ó7 3 2

When Rifkin opposes the new

biotechnologies by claiming that they are destructive to the environment, he is really arguing that those technologies do not foster the nature that he wants to live in--one compatible with his own green world view.7 3 3

Because the nature that Rifkin wants to live in may not

necessarily correspond to reality in the world view of rDNA proponents, he has been forced to argue in the only terms that proponents will engage--the safety issue. consequences.

Focus on safety considerations had two major

First, it provided a home-field advantage for those who

believed that only experts should be involved in science policy decision making.

Second, it created a smokescreen for the more acrimonious

underlying social controversy in which Rifkin, and others, wanted to engage.

The Committee for Responsible Genetics - Another Green Perspective Although Rifkin is clearly the most extreme, outspoken, and sensational opponent of rDNA technology, he was not isolated in his ideology.

Another public interest group that participated in the rDNA

technology debate was the Committee for Responsible Genetics (CRG). 731

It

Rifkin, Jeremy and Ted Howard, (1977). Redneck Power; the Wit and Wisdom of Billy Carter. New York, Bantam Books. 732 Buttel, Frederick H., (1992). ÒEnvironmentalism: Origins, Processes, and Implications for Rural Social Change.Ó Rural Sociology. v. 57 (1) pp. 1-27. 733 For a in-depth analysis of this concept see Bird, Elizabeth Ann, (1987). ÒThe Social Construction of Nature: Theoretical Approaches to the History of Environmental Problems.Ó Environmental Review. v. 11 (4) (Winter) pp. 255-264.

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grew out of the Coalition for Responsible Genetic Research, which had become inactive, and reorganized in Boston, Massachusetts in 1982.7 3 4 The CRG is a ÒU.S. based, non-governmental organization of scientists, public health advocates, trade unionists, environmentalists, feminists, disability activists, and other concerned citizensÓ whose purpose is Òto consistently challenge the direction of the biotechnology industry.Ó7 3 5 Among the guiding principles of the CRG is the statement that Òproblems rooted in poverty, racism, and other forms of inequity cannot be remedied by technology alone.Ó7 3 6

Arguments presented in the CRGÕs

activist bulletin, GeneWATCH, are science based.

However, it is clear

that a liberal philosophy of public inclusion in decision making and public control of both public and private technologies provides a substructure for the scientific arguments presented in the organizationÕs mainly negative assessments of the safety of biotechnology7 3 7 . CRG goals and objectives are consistent with the now defunct New Left Social Movement and the current Green Party.

Although

publications of the CRG feature scientific data and rhetoric, guiding principles, board member profiles, and programs of the CRG clearly indicate an agendum of social justice pursuits.7 3 8 For example, the CRG 734

Premier issue (November/December, 1983) of G e n e W a t c h, the newsletter of the Committee for Responsible Genetics, Boston MA, p.1. The name was changed again in 1991 to ÒCouncilÓ for Responsible Genetics. 735 Council for Responsible Genetics, (1994). GeneWATCH, 10th Anniversary Issue. Cambridge, MA, CRG. 736 From an undated CRG pamphlet; Date is certainly between 1991 and 1995. MEJ personal archive. 737 See these issues of GeneWATCH: vol. 1, no. 3-4, May-August, 1984; vol. 2, no. 1, January-April, 1985; vol. 2, no. 4-6, November-December, 1985; vol.5, no. 2-3, March-June 1988; 738 For example, Barry Commoner was the CitizenÕs Party presidential candidate in 1980. Nobelist Linus Pauling was a co-signer of a ÒCall to resist legitimate authorityÓ in 1967. (Unger, Irwin, (1974). The Movement: A History of the American New Left, 1959-1972. New York, Dodd, Mead & Co.) Nobelist George Wald

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mission includes the politics of environmentalism, human rights, and citizen empowerment Òto bring [rDNA] technologies under democratic control.Ó7 3 9

Among the members of CRGÕs governing boards are such

prominent scientists as Liebe Cavelieri, Jonathan King, Stuart Newman, Barry Commoner, Stephen Jay Gould, Jonathan Beckwith, Richard Lewontin, David Pimentel, Ruth Hubbard, and Nobel Laureates Linus Pauling and George Wald.

Isolating Big Business as Villain Each major technology has had its critics, fearmongers, and Luddites; mainly aimed at the technology itself.

However, even Rifkin has

admitted that some products of biotechnology can be beneficial.7 4 0 Rifkin does not f e a r rDNA technology--he fears control of the working classes by wealthy corporate stockholders. agitate for social reform.

He u s e s the rDNA debate to

It is convenient for him that rDNA came along

when it did, because when the American Bicentennial was over, he needed new anti-big business campaign material. RifkinÕs strategy was to keep the legal costs and delays of bringing rDNA products to market prohibitively high.

Under such conditions,

was noted for his anti-war activities and Lewis Mumford, a noted writer of books about the dehumanization of society by technological progress, was on the board of the original CRG in New York. (Microsoft Corporation, (1996). M i c r o s o f t Encarta 97 Encyclopedia Deluxe Edition, Version 1.0. Redmond, WA.) Jonathan King, a molecular biologist at MIT, was a prominent member of Science for the People, an organization of politically radical-Left scientists. (Bennett, William and Joel Gurin, (1977). ÒScience that Frightens Scientists: The debate over DNA.Ó The Atlantic Monthly. v. 239 (February) pp. 43-62.) Stuart Newman applied for a patent on creating human hybrids to force the Patent and Trade Office to grapple with the morality of patenting life forms. Uncited author, (1998). ÒPatent Sought for Human Hybrids.Ó Washington Post. Washington, DC. Friday, April 3, p. A3. 739 Letter from Wendy L. McGoodwin, Executive Director of CRG, to Mary Ellen Jones, dated February 3, 1995. MEJ archive, Folder: CRG. 740 Crossfire with Tom Braden and Bob Novak (1987). John Fulkerson, USDA, versus Jeremy Rifkin, FET. CNN-TV. April 20. Washington, D.C.

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small companies could scarcely afford to engage in research and development.

Only the multinational corporations and the federal

government could be in the game because only they could afford the litigation.

This strategy effectively isolated the multinational

corporations and traditional government agencies and made them look like the villains in the eyes of the general public.

Because rDNA was the

perfect weapon, it follows logically that Rifkin would have had no interest in resolving the rDNA controversy, thus his unwillingness to negotiate. Rifkin framed the multinationals as the only ones who stood to reap the benefits of rDNA technology while the public as a whole was forced to accept any risks to themselves and to the environment.

Rifkin was

opposed to the closed sessions of the RAC that afforded protection to confidential business information.

Rifkin also opposed the RACÕs review

of private sector protocols because the actions would help to insulate the corporations from liability should some unexpected mishap occur. By receiving NIH approval on voluntarily submitted private sector protocols, Rifkin claimed that the multinationals were handed, in essence, a free insurance policy backed by the federal government.

He

could then frame the traditional political institutions of the U.S. Government, not only as inadequate and powerless to stop the villains, but as aiding and abetting them.

Attacking the Administration as Corporate Accomplice With a new perspective on RifkinÕs campaign, it is perhaps easier to understand, if not condone, his persistent chiseling away at the development of rDNA technology at every possible opportunity.

It is

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also easier to conceive of the method behind his claims that there are insufficient data to assure the safety of rDNA to the environment while at the same time he makes every effort to ensure that no risk assessment studies are able to take place.

RifkinÕs activities of 1984,

including his civil case FET v. Heckler and his persistent nagging of the RAC, represented only the beginning of his crusade against environmental release of rDNA--or more precisely, against multinational corporations. From 1984 through 1986, Rifkin continued to harass the Administration for its collaboration with multinational corporations in facilitating the environmental release of rDNA.

He brought numerous

lawsuits against the government on a wide variety of rDNA topics from microorganism releases and transgenic animals to biological warfare and germplasm conservation.7 4 1

Even the White House was not immune

from Rifkin aggravation when he sued the Office of Science and Technology Policy and six other agencies over Coordinated Framework.7 4 2

the content of the

Most of his litigation was based on lack of

compliance with NEPA. RifkinÕs use of the justice system in his battle against corporate America may have had the effect of making rDNA researchers more considerate of the external effects of their activities--if it did not cause them to abandon their projects altogether.

According to a National

Association of State Universities and Land Grant Colleges (NASULGC) 741

For an annotated list of Rifkin civil actions against the U.S. government with citations, filing dates, and decision dates, see Krimsky, Sheldon, (1991). Biotechnics and Society: The Rise of Industrial Genetics. New York, Praeger., at pp.123, Table 7.1. 742 FET v. Johnson, et al. Civil Action No. 86-1956, U.S. District Court for the District of Columbia. Filed July 15, 1986. Decided December 22, 1986.

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report, ÒThe lawsuits challenging the propriety of biotechnological experimentation have surely affected progress in scientific development.Ó7 4 3

Many of RifkinÕs strategies were designed to short

circuit the ability of the multinational agricultural giants to benefit from the new biotechnologies.

However, it will suffice as an illustration of his

effect on agricultural biotechnology policy to review only those cases which refer to Ice-Minus. Rifkin had been granted several injunctions as a part of the lawsuit, FET v. Heckler against both federally funded university (U.C.-Berkeley) and non-federally funded private sector AGS protocols for Ice-Minus type bacteria.

He had received a restraining order to prevent the

discussion of the AGS protocol at the February, 1984 RAC meeting.

The

RAC approved the AGS application at the June 1, 1984 meeting and had published an Environmental Assessment Finding of No Significant Impact (EA-FONSI) for the U.C.-Berkeley application in August of the same year.7 4 4 Recall that EPA had claimed jurisdiction over rDNA microbial pesticides in 1983 (Chapter Seven).

In August of 1985, EPA publicized

the receipt of a request from AGS for an experimental use permit to perform field tests of ÒFrostban,Ó the AGS version of Ice-Minus.7 4 5 The ink had not yet dried on EPAÕs permit to AGS when on November 14,

743

Committee on Biotechnology, Division of Agriculture, NASULGC, (1986). Emerging Biotechnologies in Agriculture: Issues and Policies. National Association of State Universities and Land Grant Colleges. November. Progress Report. 5., at p.36. 744 RAC meeting minutes of June 1, 1984. Also, draft of environmental assessment and FONSI for Ice-Minus. Under memo from the NIH legal advisor, Robert Lanman, dated August 29, 1984, requesting comments from ten experts. Tolin Archive, Box #2, Folder: 1984. 745 (50 FR 33841) August 21, 1985.

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1985 Rifkin filed suit against EPA Administrator, Lee Thomas,7 4 6 claiming that EPAÕs review of the AGS proposal under FIFRA was inadequate and not functionally equivalent to a NEPA review.7 4 7 Rifkin was quoted as having said, ÒIf they havenÕt even devised the methods to determine risk, how can they say the experiment is safe?Ó7 4 8

These

reprimands were issued despite EPAÕs conditional granting of the permit, which required that the AGS study include some risk assessment data collection, for example, by sampling of the air above the test field to see if any of the rDNA organisms had Òescaped.Ó7 4 9 RifkinÕs circular argument--that testing should not be allowed before risk methodology is developed, but that collection of risk data is not safe, therefore should not be permissible--may make no sense scientifically; but it does make sense if the intent is to use a confusing technological controversy for political purposes. EPA announced the conditions of the AGS experimental use permit in the December 4, 1985 Federal Register.

For example, EPA required that

the person making the field application of the rDNA organisms Òwill wear full protective clothing including goggles and respirator; applications will be made only during calm weather to decrease drift; a 12 hour reentry interval after application will be observedÓ as well as monitoring protocols to detect drift.7 5 0 746

Only one set of comments was

FET v. Thomas, Civil Action No. 85-3649, Filed November 14, 1985, U.S. District Court for the District of Columbia. See also Committee on Biotechnology, Division of Agriculture, NASULGC, (1986). Emerging Biotechnologies in Agriculture: Issues and Policies. National Association of State Universities and Land Grant Colleges. November. Progress Report. 5., at p.26. 747 at p.27. 748 Hilts, Philip J., (1985). ÒEPA Clears Way for Release of New Antifrost Microbe.Ó Washington Post. Washington, D.C. November 15, p. A2. 749 Ibid. 750 (50 FR 49760) at p.49761. December 4, 1985.

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received following the first announcement in August.

287 This was from

Rifkin and the same alliance of groups who had filed the original FET v. Heckler lawsuit in 1983.

They stated that Òf u r t h e r testing is needed to

evaluate the potential for the [Ice-Minus] products to survive, multiply, and be dispersed in the environment.Ó 7 5 1

Ironically, (and no doubt

intentionally) a n y field testing is what their lawsuits were designed to prevent. The release of rDNA organisms into the environment was getting closer to realization.

It is likely that an activist as seriously committed

as Rifkin would not be caught napping while waiting for the outcome of his own federal lawsuits.7 5 2

Rifkin could have broadened his attack by

calling in radical relief from international and local constituencies.

By

January, the Monterey County (CA) Board of Supervisors (the intended location for the AGS test) announced its opposition after receiving a telegram from Òmore than two dozen members of the Green Party in the West German Parliament.Ó7 5 3

In February, Rifkin vowed to help local

groups with litigation.7 5 4 Adding to RifkinÕs side of the scorecard, a disgruntled AGS worker is said to have contacted Rifkin to report that AGS had illegally tested its Frostban bacteria on a roof top at its headquarters b e f o r e the EPA had issued its approval.7 5 5

In February of 1986, the scandal came to the

publicÕs attention via a series of articles by Washington Post staff 751

Ibid., at p.49762. Emphasis added. My conjecture, based on a comprehensive analysis of RifkinÕs work. 753 Uncited author, (1986). ÒCritics Call Genetic Experiment Risky.Ó Roanoke Times and World-News. Roanoke, VA. January 19, p. A16. 754 Uncited author, (1987). ÒAnti-Frost Bacteria Test.Ó New York Times. New York. February 12, p. D5. 755 The existence of a whistle blower at AGS contacting Rifkin is reported by Krimsky, Sheldon, (1991). Biotechnics and Society: The Rise of Industrial Genetics. 752

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writer, Philip Hilts.7 5 6

288

Rifkin immediately took advantage of the

situation saying, ÒAGS sent a message to the entire world that the industry is not to be trusted with the responsibility of policing itself.Ó7 5 7 The EPA withdrew the experimental use permit and fined the company.7 5 8 While the AGS protocol stewed in scandal, the U.C.-Berkeley proposal gained ground.

On a parallel track for the field test finish line, Lindow

and Panopoulos received their experimental use permit from the EPA in May of 1986.

Soon after, on June 9, 1986 Rifkin again sued EPA, this

time for failing to develop financial liability standards to ensure that companies which have been given experimental use permits have shown that they can take financial responsibility for mishaps.7 5 9 The U.C.-Berkeley test was on the verge of debut in August, when Rifkin managed to recruit Californians for Responsible Toxics Management as co-plaintiffs to block the experiment, charging that another environmental assessment in compliance with CaliforniaÕs Environmental Quality Act would be required.

Again, U.C.-Berkeley

delayed the test in order to comply with activist demands.7 6 0

New York, Praeger. See p. 131. 756 Hilts, Philip J., (1986). ÒBacteria Tested Outdoors Without U.S. Approval.Ó Washington Post. Washington, D.C. February 26, p. A3. 757 Hilts, Philip J., (1986). ÒTest of Altered Microbe Was Illegal, EPA Says.Ó Washington Post. Washington, D.C. February 27, p. A3. 758 Hilts, Philip J., (1986). ÒEPA Halts Testing of Microbe: Company is Fined, Stripped of License.Ó Washington Post. Washington, D.C. March 25, p. A5. 759 FET v. Thomas No. 86-1590, D.D.C. Decided December 22, 1986 760 Crawford, Mark, (1987). ÒCalifornia Test Goes Forward.Ó S c i e n c e. v. 236 (May 1) p. 511. The case eventually died and went unreported because California Superior Court Judge Darrel W. Lewis denied a restraining order for the Berkeley test, and the AGS test took place before the final decision of the court. FET and Californians for Responsible Toxics Management v. Regents of University of California, Cal. Super. Ct. No. 342097 filed August 1, 1986, decided April 23, 1987.

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Frostban Field Day The following spring, AGS had complied with all federal requirements and prepared to test their version of Ice-Minus bacteria. Under the cover of darkness during the night of April 2, 1987, and less than twenty-four hours after a California Superior Court judge refused a last minute request for a preliminary injunction by local environmentalists,7 6 1 vandals entered the test site and, in a last ditch effort to foil Frostban, tore up over 2,000 strawberry plants.7 6 2 AGS workers quickly replanted most of them so the test could go on as scheduled. The field trial began at

about 6:30 am on April 24, 1987 in a

strawberry patch in Contra Costa County, California, about 50 miles east of San Francisco.7 6 3

As an indication of his faith in the safety of the

product, AGS Director of Product Research, Trevor Suslow, allowed his two small children to play in the field while the Frostban was being sprayed, then ate one of the sprayed strawberries.7 6 4

The event made

good press and an even better photo opportunity for the throngs of reporters who had gathered for the fanfare.

Researcher Julie

Lindemann wore the required Òmoon-suitÓ application gear that was considered appropriate when working with highly toxic chemicals.7 6 5

761

The environmental coalition was made up of Earth First!, RifkinÕs FET, and the Berkeley Greens. Krimsky, Sheldon, (1991). Biotechnics and Society: The Rise of Industrial Genetics. New York, Praeger. See p. 132. 762 Uncited author, (1987). ÒAltered Bacteria Released.Ó Science News. v. 131. May 2. p. 277. Also Hilts, Philip J., (1987). ÒGene-Altered Bacteria Tested in Berry Patch.Ó Washington Post. Washington, DC. April 25, p. A4. 763 Crawford, Mark, (1987). ÒCalifornia Test Goes Forward.Ó S c i e n c e. v. 236 (May 1) p. 511. 764 Hilts, Philip J., (1987). ÒGene-Altered Bacteria Tested in Berry Patch.Ó Washington Post. Washington, DC. April 25, p. A4. 765 A Washington Post photo shows the moonsuit sporting an emblem reminiscent

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Just out of camera range, the media wore street clothing and enjoyed coffee and donuts.7 6 6 Although frost would have been long gone from the San Francisco area by late April, there was still the opportunity to collect data about microbial survival rates.7 6 7

Five days later, on April 29, Steven Lindow

finally tested his Ice-Minus bacteria on a tiny potato field in Tulelake, in northern California--relatively unnoticed by the media.7 6 8 Preventing the field testing of rDNA microorganisms had become a dead issue for Rifkin, as well as for the media, following the AGS and Lindow field tests.

Rifkin continued to litigate on other bases, but by

1987, his overall litigation against agriculture had subsided somewhat.7 6 9

Although the rDNA controversy Release Era had not yet

reached another quasi-quiescent stage, the period of conflict began to decline following the field tests of Frostban and Ice-Minus, which occurred without mishap.

Summary An analysis of Jeremy RifkinÕs many books indicates that Rifkin does not f e a r rDNA technology--he u s e s the rDNA debate to agitate for social

of the logo in the movie, ÒGhostbusters,Ó that said ÒFrostbusters.Ó Ibid. Hilts, Philip J., (1987). ÒGene-Altered Bacteria Tested in Berry Patch.Ó Washington Post. Washington, DC. April 25, p. A4. 766 Personal communication with Sue A. Tolin, Ph.D. Professor of Plant Pathology, Physiology, and Weed Science, Former USDA representative to the NIH-RAC and OECD. Virginia Tech (various dates in 1998, 1999). 767 Uncited author, (1987). ÒAltered Bacteria Released.Ó Science News. v. 131. May 2. p. 277. 768 Krimsky, Sheldon, (1991). Biotechnics and Society: The Rise of Industrial G e n e t i c s. New York, Praeger. See. p.132. 769 Committee on Biotechnology, Division of Agriculture, NASULGC, (1987). Emerging Biotechnologies in Agriculture: Issues and Policies. National Association of State Universities and Land Grant Colleges. November. Progress Report. 6., at p.32.

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Rifkin believes that U.S. based multinational corporations stand

in the way of his ideal society, and he will use any available weapon against them.

Biotechnology, in the hands of the multinationals, was

construed as a threat to the environment and the working classes. Therefore, RifkinÕs attacks on Ice-Minus in particular and rDNA technology in general were, within the context of his green world view, both reasonable and predictable.

Others with green ideologies like

RifkinÕs included the Committee for Responsible Genetics, an activist group with ties to the New Left political movement of the midtwentieth century. Thus far, I have examined the Republican AdministrationÕs efforts to promote the development of rDNA technology as part of its campaign aimed at fostering competitiveness of American business.

I have also

analyzed the radical tactics of Jeremy Rifkin, a prominent member of the Green movement in America, who struggled to put public interests ahead of profits.

Next I turn my attention to the strategies of those who

wanted the best of both worlds--a competitive new technology, with public confidence behind it.

In the last chapter of Part III, I examine

the activities of a group of young Democratic Congressional aides who called themselves Òthe Cloneheads.Ó

By controlling the activities of

Congressional Committees, the Cloneheads leveled the playing field of science policymaking for public participation.

CHAPTER 11: DEMOCRATS AND DNA: CLONEHEADS TRY TO FIX THE FEDERAL FRAMEWORK Introduction It is unfortunate that history tends to overlook failed attempts to overthrow the status quo--unless those revolutions are particularly bloody or lengthy.

Such exclusion results in a somewhat linear

narrative without examination of potential alternatives, or Òpaths not taken.Ó

History also often ignores the contributions and opinions of

those other than the famous (or infamous) players.

Yet the

contributions, beliefs, and actions of obscure support staff do have an effect on overall outcomes of controversies; or they at least provide insight for future problem solving.7 7 0 This chapter centers on an informal group of Congressional aides for the Democratic Congressional leadership during the late 1980s who called themselves the ÒCloneheads.Ó

This group played a key behind-

the-scenes role in the rDNA debate during the late 1980s.

I also

summarize the attempts made by some members of this heretofore unknown coterie of Capitol Hillocrats7 7 1 to promote the politically 770

The value in examining the contributions of lesser known individuals in science controversies is explored in Desmond, Adrian, (1989). The Politics of Evolution: Morphology, Medicine, and Reform in Radical London. Chicago, University of Chicago Press. Desmond examines the role of non-Aristocrats in the shaping of medical curricula with regard to evolutionary theory in 19th Century England. 771 ÔHillocratsÕ is a term I use to designate non-elected federal employees who work on Capitol Hill. Elected officials come and go, but career congressional staff make up the institutional memory of Capitol Hill. Although the average tenure is less than three years in any given job description, some aides stay longer by moving among Member offices, congressional committees, and other Capitol Hill institutions. The transfer of people and resources is a very fluid process in Washington. Evidence of this phenomenon can be seen in the ÒYellow BooksÓ

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Democratic principles of centralized, public control of a powerful technology.

One example was a Clonehead led effort to ÒfixÓ the

Coordinated Framework by way of the Omnibus Biotechnology Act of 1990, a piece of legislation which would have made U.S. rDNA policy harmonize more closely with that of the European Economic Community (EEC).

The EEC developed a comprehensive process-based policy for

rDNA that required each member country to establish new regulations specifically for the oversight of biotechnology. periodicity to the rDNA debate.

I argue that there is a

By examining this path not taken, we

may better understand that some political goals underlying the rDNA debate have remained unsatisfied and may resurface during the Global Era of the controversy. The 1986 national elections returned control of the U.S. Senate to the Democrats.

With this change came an opportunity for unified

Democratic leadership in both Houses of Congress to use the rDNA debate to political advantage.

In order to understand the role of rDNA

as a valuable political vehicle, it is first essential to understand a few Capitol Hill basics.

Capitol Hillocrats In the same way that the Executive Branch contains lower ranking agency officials who hold the institutional memory, maintain political connections, and enjoy relative freedom to work within bounds set by their leadership, so does the Legislative Branch.

The elected Members

of Congress can change, but institutional memory rests with the career Hillocrats who staff the House and Senate Committees and private Congressional and Federal directories which are published four times a year and

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offices of the Congressional Representatives and Senators.

In the

personal offices of Members, many preliminary decisions are made by up-and-coming young politicos in their twenties.

What they lack in

worldly experience, they make up for in stamina and enthusiasm.

They

are for the most part bright, impressionable people who want to Òmake a difference,Ó or at least simply to Òmake it,Ó in Washington.

Many of

these Congressional Aides have political ambitions of their own.

In the

98th and 99th Congresses (1983-1986), sixteen Members of the House of Representatives, ten of whom were Democrats, had been Congressional Aides prior to becoming elected.7 7 2 Although elected Members ultimately accept the responsibility of deciding public policy, it is the aides who research the issues, interact with visitors and lobbyists, and draft letters, speeches, and publishable articles for their bosses.

It is the senior aides who draft the legislation

and reports and who decide which items are important enough to present to the Members for consideration.7 7 3

Experienced senior aides

often move to Congressional committee staff assignments, where they can work exclusively on more narrowly defined topics. The AAAS Fellows Program represents a unique post-doctoral opportunity for trained scientists to serve in an advisory capacity to Members of Congress and their aides while learning the ways of Capitol Hill.

AAAS Fellows are paid by scientific associations to work in the

still cannot seem to keep up with personnel changes. 772 Ornstein, Norman J., Thomas E. Mann and Michael J. Malbin, (1994). Vital Statistics on Congress, 1993-1994. Washington, DC, Congressional Quarterly. See p.22, 24. 773 Zilinskas, Raymond A. and Burke K. Zimmerman, Eds. (1986). The Gene-Splicing Wars: Reflections on the Recombinant DNA Controversy. Issues in Science and Technology Series; American Association for the Advancement of Science. New York, MacMillan Publishing Company. See p.32. Also, personal experience as a

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offices of Members or on Congressional House or Senate committees at no cost to the government.

The usual tenure of AAAS Fellowships is

one to two years, although some Fellows may be hired as professional staff to stay on Capitol Hill longer.

At the professional staff level,

lawyers, not scientists, are most likely to be hired by the Congress. Therefore, most of the scientific expertise on Capitol Hill comes from former AAAS Fellows. There is a tendency for Congressional staffers, who have paid their dues on the hectic Capitol Hill scene but who wish to remain in government work, to seek management positions in federal agencies where work schedules are more conducive to family life.

From their

new agency positions, former staffers, be they lawyers or scientists, realize the importance of retaining networking contact with friends and colleagues in the Congress.

These circumstances can result in enduring

alliances among federal agency employees and the Congress, thus creating an Òinvisible collegeÓ7 7 4 of networking resources, regardless of who sits in the White House.

Legislating Science There is a tendency for Members of the majority political party to sponsor most legislation, especially if it is controversial.7 7 5 Most bills are fully expected to die in committee, many having been sponsored Graduate Congressional Fellow, (see Vita). 774 The concept of Òinvisible collegesÓ is explored in Crane, Diana, (1972). Invisible Colleges: Diffusion of Knowledge in Scientific Communities. Chicago, University of Chicago Press. 775 The reason for this phenomenon is that the majority controls the Òmark upÓ of a bill before it is sent from a committee to the House or Senate floor for a vote. During Òmark upÓ the opposing majority could in theory distort a bill with amendments until it does the opposite of what the original minority sponsor had in mind. The minority MemberÕs name would then be attached to a bill that does

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only to appeal to constituents or to send warning signals to the Administration.

The unlikelihood of passage, however, does not

preclude the authoring of bills by Members of Congress who wish to take a public stand on an issue.7 7 6

When bills finally do begin to move

(at the whim of the committee chairpersons--who are always majority Members), the majority party acts; the minority reacts. It takes a crisis to propel a bill through Congress. considered a last resort.

Legislation is

When there is a public crisis, partisan politics

take a back seat to action because no elected official wants to risk using a crisis situation as a bargaining chip.

Rarely is science an issue of

debate, or even of interest, on Capitol Hill (except for appropriations). What sets biotechnology apart from many other technologies is that it generated any interest in Òlegislating scienceÓ at all.

But was it special

because of its scientific content or because it was so useful for smokescreening other issues?

That no biotechnology bill was ever sent

to the president for signature, even when both Houses of Congress were controlled by the Democrats, suggests that rDNA release may have been viewed by the Congress not as an environmental crisis, but rather as a political opportunity.

Another possibility for the lack of biotechnology

legislation has simply to do with timing.

If public attention span on any

issue fizzles and enters a quiescent period, so does Congressional interest in that issue.

Likewise, science issues are easily brushed aside

if other, more serious concerns arise, such as the spectacular stock

not represent his or her constituencyÕs interests. 776 Ironically, knowledge that a piece of legislation is unlikely ever to come to a vote may actually increase the likelihood of using an issue for political posturing through the writing or co-sponsorship of legislation.

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market crash of 1987, or the fall of the Berlin Wall and the associated international economic crisis in 1989. Economically, the Democrats have many of the same goals as Republicans, but the preferred mechanisms for attaining those goals differ.

Whereas Republicans mold their programs around a preference

for a more constricted role of government in the affairs of industry, Democrats tend to favor more centralized control of technology, which promises more public participation, public oversight, and public accountability--all of which are expected to lead to public confidence and support of the technology.

Many leading Democrats saw good

regulations as a means of assuring public confidence in an astonishing technological breakthrough such as biotechnology.

As is evident in their

many speeches on the subject, powerful senior Congressional Representatives Al Gore, Jr., (D-TN), John Dingell (D-MI), and George Brown (D-CA), all viewed proper legislative authority (not voluntary RAC review) as the best means of assuaging public concerns and permitting the public to enjoy the benefits of biotechnology. The Democratic participatory approach includes an understanding that experts are in the best position to make technical decisions, but the benefit of broad social input for publicly funded science and technology projects is also highly valued.

Any implication that the general public is

too ignorant of scientific issues to be able to participate is found to be condescending.

Although they have co-opted the green rhetoric of

environmentalism, unlike the Green Party, Democrats do not embrace the need to restructure institutions from the ground up.

Democrats

prefer to work from within the current system to liberalize rDNA

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Biotechnology--powerful, conspicuous, and controversial--

was the perfect medium for making policy decisions more participatory.

The Cloneheads777 Members of the Cloneheads were young, well-educated, senior staffers for the Democratic leadership of several Congressional Committees that had jurisdiction over biotechnology during the 100th (1987-1988) and 101st (1989-1990) Congresses.

Some of the

Cloneheads were AAAS Congressional Science Fellows representing, for example, the American Society for Microbiology or the American Chemical Society.

Others were attorneys.

Still others were simply well-

connected, discerning people who were very savvy about the ways of Washington. The traditional competition among Congressional committees with potential jurisdiction over biotechnology was evident during the mid1980s, (the Òpre-CloneheadÓ period).

This was particularly true

between the House Energy and Commerce Committee and the House Committee on Science and Technology.

Energy and Commerce, led by

the dynamic John Dingell (D-MI), was taking the lead in biotechnology with hearings and investigations.

There was concern among senior

staffers on the House Committee on Science and Technology that biotechnology should rightfully be under the jurisdiction of the Science Committee.

777

I was able to locate and interview some of the Congressional Aides who either were members of this group or worked with them closely. I wish to thank the following people for their help in reconstructing the tale of the Cloneheads during personal interviews and E-mail communications. William (Skip) Stiles, Kathleen Merrigan, Kathy Hudson, Lesley Russell, and Irene Glowinski. Much of the information in this chapter came from those discussions.

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In 1985, new AAAS Fellows Irene Glowinski (supported by the American Chemical Society) and Eileen Lee (supported by American Society for Microbiology) wanted to work for the House Science Committee where Al Gore had been because it had a history of interest in genetic engineering and biotechnology.

After Gore left for the U.S.

Senate, attorney Gregory (Greg) Simon became Acting Staff Director for GoreÕs former Subcommittee on Investigations and Oversight, by then headed by Harold Volkmer (D-MO).7 7 8 work of Gore was important.

The staff felt that continuing the

Glowinski and Lee helped Simon with the

interpretation of the science articles, and Simon taught the women about law and politics. Glowinski recalled that she, Simon, and Lee cooperated with each other in an effort to gain some control for the Science Committee over biotechnology issues from Energy and Commerce.7 7 9

However, the

congenial cooperation among staffers from different committees would indeed have been unusual at that time.

Cooperation between

committees and even across the Capitol was something that developed after the Keystone biotechnology meetings that were held in the mid to late 1980s. The Keystone Center is a non-profit consensus-building organization, located in Keystone, Colorado, which focuses on conflict management and public policy in controversial science-related issues. 778

Many of the

Albert (Al) Gore, Jr., began his term in the U.S. Senate in 1985. After Gore, the Subcommittee on Investigations and Oversight of the House Committee on Science and Technology was chaired by Harold Volkmer during the 99th Congress (19851986) and by Robert Roe (D-NJ), who headed both the Subcommittee and the full Science Committee during the 100th (1987-1988) and the 101st Congresses (19891990). 779 Interview with Irene Glowinski, Ph.D. former ACS Congressional Fellow, House Committee on Science and Technology, Subcommittee on Investigation and

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Cloneheads initially became acquainted with one other, not on Capitol Hill, but on the snowy slopes of the Rocky Mountains at Keystone conferences.7 8 0

The Keystone series of biotechnology forums brought

together people from all sides of the rDNA controversy to engage in consensus building workshops in a congenial atmosphere.

People

attended these meetings as individuals, not as representatives of any company or agency, and discussions at all work sessions were off-therecord to encourage free exchange. consensus building process.7 8 1

Reports represented results of a

The Congressional staffers had gone to

the Keystone meetings because they needed up-to-date information on biotechnology so the Members of Congress for whom they worked could make informed policy decisions.

At Keystone, staffers developed

contacts with significant people from the world of rDNA technology and regulation.

Through the Keystone dialogues, the aides broadened their

perspective on the issues surrounding the debate. Back in Washington, these key staffers continued their new friendships.

They socialized after hours, and it was at those informal

gatherings that they shared information, coordinated their work, and began calling their little group the ÒCloneheads.Ó

The Cloneheads

immediately recognized four important things: 1 . Recombinant DNA technology would transform the life sciences. 2 . Few people on Capitol Hill knew anything about it.

Oversight. Washington, DC (December 22, 1997). 780 Some Keystone meetings were also held in Washington, DC, as well as outside the U.S. 781 Keystone Center and National Biotechnology Forum, (1989). P u b l i c Participation and Education Summary Report and Recommendations. The Keystone Center. Keystone, CO. February. report.

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3 . Any Member of Congress who could take the lead in championing a successful biotechnology campaign would leave an impressive legacy. 4 . A Òlevel playing fieldÓ was required for maximizing public involvement.7 8 2 The Cloneheads had the foresight to recognize that biotechnology was going to have a big impact on the nation.

However, it was so new and so

complex that no informational support system existed for it in laymanÕs terms.

Secondary literature on the subject was scarce.

Even the well

respected Congressional Research Service and the Congressional Office of Technology Assessment--invaluable as they were--could not provide the immediate information demanded by this cutting edge issue.

Thus,

although it was very unusual for Hillocrats to share information across committees within the House or Senate that have overlapping and conflicting jurisdictions, the Cloneheads needed each other.

They would

chase down rumors and let each other know what was going on within their own networks in the industry or federal agencies.

Their

cooperative strategy also allowed them to divide the work and share the results.

William (Skip) Stiles, who was a senior staffer for George

Brown (D-CA) on the House Agriculture Committee noted the unusual nature of the CloneheadsÕ alliance. ÒAll these folks were pretty open, which is uncharacteristic for Hill staffers. You know, up here, information is power and power is the currency of the day.

782

It is in the staffersÕ best interests to select issues for their bosses which will make them successful Members. Working for a successful Member of Congress who is able to build seniority provides the aide with employment security. Senior Members who have committee leadership assignments are also given extra aides to staff their committees.

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So you hoard your information, and you donÕt waste it. spend it on your friends.7 8 3

302 You

In addition, the Cloneheads provided a collegial, peer review feedback mechanism.

Kathleen Merrigan, formerly a staffer to Patrick

Leahy (D-VT), Chairman of the Senate Agriculture Committee, remembered her appreciation for the existence of the Cloneheads. ÒThere was a need for the Cloneheads. It was a technology that people didn't know much about. We felt isolated in our work and so we really needed a sounding board for ideas so we could talk through things and make sure we had it straight, with some sort of sanctuary, because it was controversial at the time. That was the purpose of Cloneheads.Ó7 8 4 The Cloneheads primarily constituted a networking system; an invisible college of individuals who were driven by the absence of easily accessible information and the need to educate themselves.

It

was not a formal organization, and no doubt the elected Members for whom the Cloneheads worked never even knew of its existence. presence did not go totally unnoticed, however.

Their

Lesley Russell was an

American Society for Microbiology Congressional Fellow who continued to work on Representative John DingellÕs House Energy and Commerce Committee as a professional staffer with responsibilities for health and biotechnology issues.

She recalled,

ÒSomewhere there is an article in the Pink Sheet where the pharmaceutical industry lobbyists got wind of the 783

Interview with William (Skip) Stiles, Senior Staff, U.S. House of Representatives, Committee on Science; formerly on staff of House Agriculture Committee. Washington, DC (November 20, 1997). 784 Interview with Kathleen Merrigan, former Congressional staffer for Patrick Leahy (D-VT), Senate Agriculture Committee. Washington, DC (December 29, 1997).

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Cloneheads and thought that it was something very sinister-a global plot!! We thought that was hilarious.7 8 5 The Cloneheads most certainly did not represent a scheming band of political rebels.

As I have indicated, it was primarily an informal group

of aides who needed each other for networking and informational purposes.

Nevertheless, the empowerment gained by information

sharing did enable them to have a collective impact on the path of rDNA regulation. As lead Committee staffers, the Cloneheads were responsible for choosing the issues that merited congressional hearings, scheduling those hearings, and even selecting the witnesses.7 8 6

The final decisions,

of course, were made by the elected Members, but the decisions about what to present to the Members were made by the staff.

When

Cloneheads needed information, they could convene meetings with Òguest speakersÓ from academia, federal agencies, or lobby groups. Aside from the power to organize hearings, as senior staffers, some Cloneheads had blanket permission to sign a MemberÕs name to a letter, or to a document in support of legislation, because they were intimately

785

E-mail interview with Lesley Russell, Ph.D. former Congressional staffer for Rep. John Dingell, U.S. House of Representatives Energy and Commerce Committee, Subcommittee on Oversight and Investigations. Sydney, Australia (March-April, 1999). I was unable to locate the so-called ÒPink Sheets.Ó 786 The staffers also wrote the reports that came out of some of those hearings. The names of these hard working aides are often inconspicuously printed in hearings transcripts and staff reports under the lists of Committee Members. For example, the names ÒGregory Simon, Irene B. Glowinski, Eileen Lee, and Carolyn Radebaugh,Ó all early members of a group of colleagues, some of whom would later call themselves ÒThe Cloneheads,Ó is listed in a staff report which summarizes the Coordinated Framework and other issues related to environmental release of rDNA organisms. U.S. Congress, House of Representatives, Committee on Science and Technology, Subcommittee on Investigations and Oversight, (1986). Issues in the federal regulation of biotechnology: From research to release. U.S. Government Printing Office. Washington, D. C. December. Report. 99/117.

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familiar with a MemberÕs position on various issues.7 8 7

304 Kathleen

Merrigan cited an example: ÒWhen you're a Senator and the chairman of ... three committees, you can only handle so much detail. [Senator Leahy said of permission to sign his name] it...gives you some rope to hang yourself with. But it's a matter of trust. We developed a level of trust with him that gave us some opportunities.7 8 8 Details are handled by staff.

The elected official is then briefed and

his or her approval is sought on significant matters that require official action.

For example, a request for a General Accounting Office (GAO)

study of FDAÕs handling of the approval of recombinant bovine somatotropin (rBST) was initiated by one of the Cloneheads in 1988.7 8 9 Other Cloneheads were recruited to ask their bosses to sign on to letters requesting the GAO audit on the adequacy of the FDA review of rBST.7 9 0 Recall from Chapter Nine that FDA was in lock step with the AdministrationÕs viewpoint that no special rules should be made for products of rDNA.

787

This power is not necessarily given to staff by all Members of Congress. E-mail interview with Lesley Russell, Ph.D. former Congressional staffer for Rep. John Dingell, U.S. House of Representatives Energy and Commerce Committee, Subcommittee on Oversight and Investigations. Sydney, Australia (March-April, 1999). 788 Interview with Kathleen Merrigan, former Congressional staffer for Patrick Leahy (D-VT), Senate Agriculture Committee. Washington, DC (December 29, 1997). 789 BST or BGH (bovine growth hormone) is a naturally occurring hormone in cattle that is involved in muscle growth and milk production. A recombinant form of it was designed to be injected into cows to increase milk production. At issue was the safety of the product to humans, to cows, to calves, and to the environment. There was also an argument advanced by critics that its adoption by large, well managed dairies would accelerate the loss of smaller family farms. 790 Interview with Kathleen Merrigan, former Congressional staffer for Patrick Leahy (D-VT), Senate Agriculture Committee. Washington, DC (December 29, 1997).

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As senior staffers, Cloneheads also drafted legislation.

For example,

the 1990 Farm Bill contained a section, which was passed into law, that was written by Senate Agriculture Committee staffer Kathleen Merrigan.7 9 1

The law, which was propelled through to a vote without

amendments because the Farm Bill was a must-pass item, required that USDA set aside not less than 1% of whatever amount of money it spent on biotechnology for risk assessment studies.

The Risk Assessment

Research Program became a part of NBIAP (See chapter Eight). Stiles carried the ball on the House Agriculture side.

Skip

David MacKenzie

at CSRS, who supervised the establishment of the NBIAP, remembered the day that Cloneheads recruited him as an information source. ÒGreg [Simon], Skip Stiles, and Kathy Hudson asked me to come to Capitol Hill and give them a seminar on NBIAP.... next thing I knew my budget was tripled. ... Kathleen [Merrigan] was our environmental voice in the Congress for getting this stuff done.7 9 2 Merrigan and MacKenzie both thought the Farm Bill approach was a reasonable one to take in calming public concerns.

They both recalled

that there was protest by the biotechnology industry against that part of the Farm Bill because it raised the aura of risk.

(The industry had

disputed the existence of any risk worth studying.)

The Cloneheads

could not pretend that risk was not an issue; if for no other reason than voters believed that it was so. The Cloneheads also did not think that the Reagan AdministrationÕs Coordinated Framework, made effective in June of 1986, was 791

Ibid. Interview with David MacKenzie, Ph.D. Executive Director, NE Regional Assn of State Agr. Experiment Stations, formerly with CSRS, USDA. Washington, DC (December 9, 1997). 792

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particularly Òcoordinated.Ó

306

The Framework represented a matrix of

authorities for regulating rDNA technologies that crosses many agencies. Was the approach confusing?

Yes; but not unusual.

For example, 23

different agencies met to coordinate the regulation of the chemical formaldehyde based on their jurisdiction over various uses of it.7 9 3 This approach may have been practical for formaldehyde, but in the case of rDNA release, there was general agreement among the Cloneheads that there were regulatory gaps in the AdministrationÕs Framework and that those gaps needed to be filled.

For example, Eric Hallerman, then an

assistant professor in the Department of Fisheries and Wildlife Sciences at Virginia Tech, testified in a House Agriculture Committee hearing (October 2, 1990) that the Coordinated Framework was Òincomplete and fraught with procedural uncertainties and legal loopholesÓ with regard to rDNA research in fish.7 9 4 Likewise, the Cloneheads doubted that existing statutes could be stretched far enough to regulate the industry effectively without snapping.

William (Skip) Stiles, a long time staffer of the House

Agriculture Committee said, ÒLook at designed to around and recombinant degrees. A

793

USDA statutes. Those are all statutes that are keep bugs out of the country. To turn them use them as permitting statutes to allow things to be released, rotates them 180 statute that is designed to keep a fire ant out of

Fanning, David W., (1988). Issues Raised by Biotechnology: A Keystone Biotechnology Discussion Paper. The Keystone Center. Keystone, CO. July 14. , See p.6. 794 U.S. Congress, House of Representatives, Committee on Agriculture and Subcommittee on Department Operations Research and Foreign Agriculture, (1990). Review of Current and Proposed Agricultural Biotechnology Regulatory Authority and the Omnibus Biotechnology Act of 1990. U.S. Government Printing Office. Washington, D. C. October 2. Hearing. 101/75. See p. 73.

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this country canÕt really be used to permit the release of a genetically engineered fire ant.Ó7 9 5 Stiles also reported that Representative George Brown (D-CA), chairman of the House Agriculture Subcommittee on Department Operations, Research and Foreign Agriculture, repeatedly cautioned against the use of exclusionary statutes to regulate rDNA release. BrownÕs preferred strategy for advancing rDNA technology for the benefit of all, like that of many of his fellow Democrats, was to use regulation as a means of assuring the public that it was being protected, while at the same time preserving American competitiveness.

Although

there was not complete agreement on h o w the problems should be solved, there was a general sharing of information and division of workload in order to advance legislation that would at least raise the regulatory issues and say that something needed to be done. On the topic of environmental release of rDNA organisms, the Cloneheads were able to level the playing field between biotechnology researchers and public interest groups.

Simply by selecting witnesses

to enable exploration of different opinions and ideas, they broadened the range of input.

For example, a hearing held in October, 1990 by the

House Committee on Agriculture to discuss options for agricultural biotechnology regulation included witnesses from government, industry, academia, and the National Wildlife Federation.7 9 6 795

Interview with William (Skip) Stiles, Senior Staff, U.S. House of Representatives, Committee on Science; formerly on staff of House Agriculture Committee. Washington, DC (November 20, 1997). 796 U.S. Congress, House of Representatives, Committee on Agriculture and Subcommittee on Department Operations Research and Foreign Agriculture, (1990). Review of Current and Proposed Agricultural Biotechnology Regulatory Authority and the Omnibus Biotechnology Act of 1990. U.S. Government Printing Office. Washington, D. C. October 2. Hearing. 101/75.

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Undermining the Uncoordinated Framework It has been said that most people would be far happier if they never knew the answer to the question, ÒHow is sausage made?Ó

Having

worked on Capitol Hill, I am convinced that the same could be said for the question, ÒHow are national policies negotiated?Ó

Sometimes

hearings and public deliberation are not enough to advance an agenda. When an issue is very important, other supportive actions may be employed. The Head Clonehead

Gregory (Greg) Simon has been both credited and blamed for his role in the advancement of an environmentally oriented, Democratic approach to rDNA oversight.7 9 7

Perhaps the most enterprising of the

informal group, Simon, for better or for worse, had earned the undisputed distinction of ÒHead Clonehead.Ó

Obviously interested in

politics since childhood, Simon had covered the political party gamut from President of the Teenage Republicans of Arkansas, to press secretary for the CitizenÕs Party presidential candidate, Barry Commoner, in 1980.7 9 8

(Commoner was a pioneer in the creation of the

environmental movement.)

From 1985 until 1991, Simon was staff

director of the House Science Subcommittee on Investigations and Oversight (I&O), first under Harold Volkmer and then under Robert Roe. In 1991, Simon would move on to Al Gore, Jr.Õs Senate staff as

797

Unfortunately, Mr. SimonÕs office turned down repeated requests for an interview with him in 1997. Remarks regarding his role in these events are based on at least two corroborating interviewee statements or on published materials. 798 Browning, Graeme, (1993). ÒIn Person: Greg Simon--The White House's Window on Biotech.Ó The National Journal. v. 25 (No. 30) p. 1882.

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Legislative Director, and finally, in 1993, he would become domestic policy advisor to now Vice President Gore.7 9 9 In the credit column are comments from fellow Democrats who were impressed with SimonÕs drafting of the Omnibus Biotechnology Act for Congressman Robert Roe to present to the House of Representatives (see below).

Simon did extensive interviews and worked hard to craft a bill

that would cover the deficiencies of the Coordinated Framework and please everyone.8 0 0

The Omnibus Biotechnology Act would ultimately

have given a greater measure of power over rDNA release to the EPA. Elizabeth Milewski, of the EPA, said she viewed Simon as an ally; as someone who made a lot of sense to her.8 0 1

Even White House staffer,

John Cohrssen, who by this time was the Associate Director of President BushÕs Council on Competitiveness and who completely disagreed with the need for a legislative approach in this matter, admitted he had to give Simon credit for the way he tried to push the Omnibus Biotechnology Act through what by then was a Congress indifferent toward the rDNA release issue.8 0 2 On the other hand, Greg Simon has also been blamed for the elimination of two of the ÒThree MusketeersÓ of the Reagan Administration (Henry Miller, David Kingsbury, and John Cohrssen) who

799

Ibid. Interview #2 with Shirley Ingebritsen, Senior Regulatory Specialist, APHIS, USDA. Washington, DC (October 2, 1997). 801 Interview with Elizabeth Milewski, Ph.D. formerly on staff at NIH-ORDA, presently Special Assistant for Biotechnology, EPA. Washington, DC (December 5, 1997). 802 Interview with John Cohrssen, J.D. former legal counsel, Cabinet Council Working Group on Biotechnology, Reagan Administration. Washington, DC (December 19, 1997). 800

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he felt stood in the way of a more Democratic, participatory approach to rDNA regulation.8 0 3

Henry Miller wrote in his book,

Ò...as a congressional staffer, Simon had hounded Kingsbury from government with unsubstantiated charges of conflict of interest.Ó8 0 4 In the same paragraph of his book, Miller disguised his own dismissal from government, allegedly at SimonÕs hands. ÒAlso while working for the vice president [Gore] Simon improperly ordered FDA to remove a senior civil servant at the Food and Drug Administration from his position.8 0 5 That Kingsbury and Miller were victims of political vandalism is apparent.

The third ÒMusketeerÓ John Cohrssen, also reported not

having been exempt from harassment by Simon.

Cohrssen said, ÒGreg

Simon was unsuccessful in his vicious and repeated efforts to discredit me and get me fired.Ó

However, I submit that, although it appears to be

true that Gregory Simon certainly participated in the removal of these high ranking officials from their posts, he did not do it single-handedly. Other persons, Cloneheads or not, were certainly involved.8 0 6

Because

there are no written documents available on these matters, it may be years before the full story emerges. 803

Alvin Young, who formerly worked both as Bernadine HealyÕs aide at OSTP and as the Director of the USDA Office of Agricultural Biotechnology, referred to these three men as ReaganÕs ÒThree MusketeersÓ because their views on how rDNA should be handled were so similar. Interview with Alvin L. Young, Ph.D. former Director, Office of Agricultural Biotechnology, USDA, and Executive Secretary of the ABRAC, USDA. Washington, DC (November 7, 1997). 804 Miller, Henry I., (1997). Policy Controversy in Biotechnology: An Insider's V i e w. Austin, R.G.Landes Co. See p.73. 805 Ibid. 806 As I have indicated, The ÒCloneheadsÓ was primarily an informal group of aides who needed each other for informational purposes. This was n o t a group that deliberately strategized to remove individuals standing in the way of its goals.

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The Cloneheads as a group did not completely trust the biotechnology industry to police itself. scientific misconduct.Ó8 0 7

In particular, Greg Simon was Òfascinated by In March of 1986, Simon and his staff of

Cloneheads on Harold VolkmerÕs Subcommittee on Investigations and Oversight (House Science Committee-I&O) had orchestrated a thorough investigation of Advanced Genetic Sciences for their improper testing of Ice-Minus bacteria before being issued an Experimental Use Permit by the EPA (see Chapter Ten).8 0 8

Simon also arranged a extensive hearing

on June 28, 1989 for House Science Committee chairman Robert Roe (DNJ). In the summary of Maintaining the Integrity of Scientific Research, the I&O Subcommittee concluded that it should have little confidence in the ability of universities or federal agencies to respond fairly and effectively to allegations of scientific misconduct. 8 0 9 The Kingsbury Affair - Political Sabotage?

One of the I&O SubcommitteeÕs targets for alleged conflict of interest was BSCC chairman, David T. Kingsbury of the NSF. Kingsbury had become a powerful icon of the AdministrationÕs Coordinated Framework when he announced to the press the June 26, 1986 adoption of the national policy for biotechnology oversight.

Although Kingsbury had

disclosed his involvement with a small biotech company in California The power of the Cloneheads was in networking and information sharing. 807 Interview with Kathy Hudson, Ph.D. former ASM Congressional Fellow, House Agriculture, Research Subcommittee. Washington, DC (December 22, 1997). 808 U.S. Congress, House of Representatives, Committee on Science and Technology, Subcommittee on Investigations and Oversight, (1986). ÒIce-MinusÓ: A case study of EPA's review of genetically engineered microbial pesticides. U.S. Government Printing Office. Washington, D. C. March 4. Hearing. 99/117. 809 U.S. Congress, House of Representatives, Committee on Science Space and Technology, Subcommittee on Investigations and Oversight, (1990). M a i n t a i n i n g the Integrity of Scientific Research. U.S. Government Printing Office. Washington, D. C. December 4. Hearing Summary. 101-J.

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when he was being considered for the position at NSF, the apparent conflict of interest presented an opportunity to embarrass the Republican Administration by discrediting the Coordinated Framework as the product of a vested interest scheme.

The logical response to such

a problem would be for the Democratic Congress to legislate a fix of the federal framework. Early in 1985, soon after David Kingsbury had taken the reins from Bernadine Healy and had begun to lead the negotiation of the Coordinated Framework, it became obvious that he and the EPA were not going to see eye to eye on the redefinition of rDNA as a Ònew chemicalÓ so that EPA could regulate it under TSCA.

A few years later,

Kingsbury sat in the lobby of the Saint Francis Hotel in San Francisco with an unnamed member of the White House staff who predicted personal disaster. ÒI didn't pay any attention to it ... but he really gave me some excellent advice. He told me Ôthey're going to assassinate you. I can guarantee it. You've run afoul of EPA. They're going to assassinate you.Õ ... Anyway, he warned me. I just didn't get it. But he was right.8 1 0 In an interview for the National Journal, Simon took credit for KingsburyÕs 1988 resignation.8 1 1

By KingsburyÕs count, a grand jury and

the Justice Department spent three-quarters of a million dollars investigating the alleged conflict of interest, and found nothing.

After

Kingsbury left the NSF post, the Department of Defense approached him

810

Interview with David T. Kingsbury, Ph.D. former Assistant Director, Biological, Behavioral, and Social Sciences, National Science Foundation. Washington, DC (December 15, 1997). 811 Browning, Graeme, (1993). ÒIn Person: Greg Simon--The White House's Window on Biotech.Ó The National Journal. v. 25 (No. 30) p. 1882.

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with an assignment which required top security clearance.

313 The Navy

conducted its own investigation into the alleged conflict of interest, and also found nothing.8 1 2

The same evidence had convinced some that

Kingsbury was guilty, others that he was not.

Guilty or not, the

harassment resulted in his resignation and a smudge on the AdministrationÕs Coordinated Framework. The Miller Affair - A Roasted Turkey

As liaison representative to the RAC from the FDA, Henry I. MillerÕs outspoken style and his opinions regarding the superfluity of federal oversight of rDNA were infamous.

He was, in some ways, as radical as

Jeremy Rifkin--but in the opposite direction. Rifkin was present, Miller,

At RAC meetings when

on more than one occasion referred to

RifkinÕs Òhigh nuisance to substance ratio.Ó8 1 3

In addition, at the October

29, 1984 RAC meeting, Miller confronted Dr. Michael Fox by calling his testimony Òa rather absurd presentation [with] glaring factual errors.Ó8 1 4 Rifkin and Fox were not the only objects of MillerÕs frequent ad hominim attacks.

Miller often ridiculed Terry Medley of APHIS, and

Elizabeth Milewski (especially after she transferred to the EPA), and apparently anyone else who did not see the world through his own lenses.8 1 5 812

Interview with David T. Kingsbury, Ph.D. former Assistant Director, Biological, Behavioral, and Social Sciences, National Science Foundation. Washington, DC (December 15, 1997). 813 Minutes of RAC meeting, October 29, 1984, p.24. U.S. Department of Health and Human Services, (1986). Documents Relating to "NIH Guidelines for Research Involving Recombinant DNA Molecules" September 1984 - March 1985, Office of Recombinant DNA Activities, NIH Publication No. 86-2864. 814 Ibid. 815 Interview with Terry L. Medley, J.D. former Director of USDA-BBEP and Administrator of APHIS, USDA. Washington, DC (December 11, 1997).; Interview with Elizabeth Milewski, Ph.D. formerly on staff at NIH-ORDA, presently Special

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At the RAC Working Group on Release into the Environment meeting of October 5, 1984 Miller had characterized the Gore Report as ÒamateurishÓ.

This attack, the first of many by Miller on Al Gore, would

in all likelihood play a role in ending MillerÕs career in federal government.

In fact, after Miller left the federal government, he did

not hesitate to accuse the vice president publicly of Òpowerful idiocy.Ó8 1 6 Thanks to the loyal Cloneheads, on the occasion of a November 14, 1985 Environmental and Energy Study Conference hearing, Al Gore was able to make roast turkey out of Henry Miller.8 1 7 Miller had taken over the review of a position document, later called the ÒBlue Book,Ó for the U.S. delegation to bring to the international OECD biotechnology meeting.8 1 8

The document, which had been drafted by

members of the OECD Group of National Experts in Biotechnology, which included Elizabeth Milewski (then of NIH), Sue Tolin (USDA), and Carl Mazza (EPA), had been ridiculed by Miller as Òseverely flawed,Ó Òinexplicably negativeÓ toward rDNA, and based on speculative risk.8 1 9

Assistant for Biotechnology, EPA. Washington, DC (December 5, 1997).; Miller, Henry I., (1997). Policy Controversy in Biotechnology: An Insider's View. Austin, R.G.Landes Co. 816 See for example a chapter entitled, ÒPowerful Idiocy: Lysenko, Gore, and U.S. Biotechnology PolicyÓ in Miller, Henry I., (1997). Policy Controversy in Biotechnology: An Insider's View. Austin, R.G.Landes Co.. 817 ÒRoast turkeyÓ was the title of a news report on the hearing which appeared during Thanksgiving week. Beardsley, Tim, (1985). ÒRoast Turkey.Ó N a t u r e. v. 318 (November 21) p. 200. 818 The ÒBlue BookÓ was a moniker for Organisation for Economic Co-operation and Development, (1986). Recombinant DNA Safety Considerations: Safety considerations for industrial, agricultural, and environmental applications of organisms derived by recombinant DNA techniques. OECD. Paris, France. 1986. Report of the Ad hoc Group on Safety and Regulations in Biotechnology. 819 Document entitled ÒFDA Comments on OECD Document, ÒSafety and Regulations in BiotechnologyÓ dated June 18, 1985 by Henry I. Miller. Tolin Archive, Box #2, Folder: turkey. This document is under a form letter headed, ÒDear Reviewer.Ó The first paragraph of the form letter asks that the reader Òplease read it very critically.Ó

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Elizabeth Milewski was present at the fateful hearing and related the relevant proceedings. ÒSo while Gore [was questioning USDA Assistant Secretary] Bentley, Henry interrupts Gore and starts lecturing Gore on how this technology is totally safe and these products are safe and that Gore essentially doesn't know what he is talking about.8 2 0 Gore stopped questioning Mr. Bentley and turned his attention to Dr. Miller, whom Gore knew had been assigned the task of collecting outside reviews for the OECD document.

Gore quizzed Miller on his

intent to conduct a fair and open process where people could give their opinions without fear of retribution.

A summary of GoreÕs turkey trap

was published in N at u r e. ÒHaving established that Miller considered himself unbiased on the regulations, Gore produced with a flourish a letter from Miller to Dr. Robert McKinney of the National Institutes of Health, in which Miller asked McKinney to review "this turkey" and be "very critical." Miller also asked what Ôthe Rifkins and Dingells will make of this.Õ8 2 1 How did Gore get the Òturkey letterÓ in the first place?

Many people

were convinced that Greg Simon was responsible--he was present at the hearing--but this hearing occurred in November, 1985, which was before Simon had been on the Hill for a full year, and before he began working for Gore.

A former Clonehead Lesley Russell confessed:

ÒThis letter went from Congressman Dingell on the letterhead of the O&I Subcommittee of Energy and 820

Interview with Elizabeth Milewski, Ph.D. formerly on staff at NIH-ORDA, presently Special Assistant for Biotechnology, EPA. Washington, DC (December 5, 1997). 821 Beardsley, Tim, (1985). ÒRoast Turkey.Ó N a t u r e. v. 318 (November 21) p. 200.

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Commerce to Al Gore in the Senate. Tony Robbins, Phyllis Freeman and I worked on the issue and briefed Gore and his staff, but I can't remember who leaked the information to us....8 2 2 As if making a personal enemy of Al Gore wasnÕt enough to seal MillerÕs fate, he later had an exchange of letters with Greg Simon in Science.8 2 3

It was clear from the letters that the two men came from

different world views on the relative importance of public oversight of rDNA release, and that neither was about to budge.

When Al Gore

became vice president, Greg Simon went along with him to the White House.

Very shortly thereafter, Henry MillerÕs position, and Miller with

it, disappeared from FDA.

Miller is convinced that Gore and Simon

wanted him gone.8 2 4

822

E-mail interview with Lesley Russell, Ph.D. former Congressional staffer for Rep. John Dingell, U.S. House of Representatives Energy and Commerce Committee, Subcommittee on Oversight and Investigations. Sydney, Australia (March-April, 1999). Anthony Robbins, M.D., a senior Dingell staffer, has published articles supporting socialization of science. See for example, Robbins, Anthony, M.D., (1984). ÒRelease of Genetically Engineered Organisms.Ó G e n e W a t c h. v. 1 (3&4) (May-August) pp. 1, 13-15. Also, Robbins, Anthony and Phyllis Freeman, (1987). ÒBiotechnology and the Public Purpose: A Public Agenda for Biotechnology in the CongressÓ in Application of Biotechnology: Environmental and Policy Issues. J. R. Fowle, III, Ed. Boulder, CO. Westview Press for the American Association for the Advancement of Science. pp. 197-224. 823 Miller, Henry I., Robert H. Burris, Anne K. Vidaver and Nelson Wivel, (1990). ÒRisk-Based Oversight of Experiments in the Environment.Ó S c i e n c e. v. 250 (October 26) pp. 490-491.; Simon, Greg, (1991). ÒBiotechnology Regulation Miller, Henry I., (1991). (Letters).Ó S c i e n c e. v. 252 (May 3) pp. 629-630.; ÒRegulation of Biotechnology (Letters).Ó S c i e n c e. v. 252 (June 21) pp. 1599-1600. 824 Miller, Henry I., (1997). Policy Controversy in Biotechnology: An Insider's V i e w. Austin, R.G.Landes Co.

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The Omnibus Biotechnology Act A Framework Fix-Up

When the leadership passed from President Ronald Reagan to President George Bush, the de facto leader of the Cloneheads, Greg Simon, had already begun drafting a regulatory bill called the Omnibus Biotechnology Act (hereafter simply ÔOmnibusÕ).8 2 5

Simon used the

Cloneheads as a sounding board while writing that bill for Representative Robert Roe, a leading Democrat from New Jersey who then chaired the House Science, Space, and Technology Committee. liked it.

They

Skip Stiles, a senior staffer for Representative George Brown

(D-CA) on the House Agriculture Committee, recalled that, ÒIt was really woven in and out of the Keystone process, because some of the ideas he got were ones that came up during those discussions at Keystone.8 2 6 The Omnibus represented an opportunity for the Cloneheads to fill the gaps that they perceived in the Coordinated Framework.

It would

have provided a comprehensive approach for oversight of all rDNA environmental releases.

It would have given authority to the USDA to

regulate rDNA releases in a manner similar to the way EPA would regulate through TSCA. 825

It would also have represented a step in the

H.R. 5312 of the 101st Congress, 2nd session. Senior staffers draft a large percentage of legislation. Only a Member of Congress can sponsor it, but anyone can draft a bill, including the president, a lobbyist, or any other citizen. A copy of the bill is reproduced in U.S. Congress, House of Representatives, Committee on Agriculture and Subcommittee on Department Operations Research and Foreign Agriculture, (1990). Review of Current and Proposed Agricultural Biotechnology Regulatory Authority and the Omnibus Biotechnology Act of 1990. U.S. Government Printing Office. Washington, D. C. October 2. Hearing. 101/75. 826 Interview with William (Skip) Stiles, Senior Staff, U.S. House of Representatives, Committee on Science; formerly on staff of House Agriculture Committee. Washington, DC (November 20, 1997).

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direction of harmonization with European rDNA policy, because it was a process-based approach to oversight. Congressman Robert Roe (D-NJ), introduced H.R. 5312, the Omnibus Biotechnology Act of 1990, on July 19.

On October 2, 1990 in testimony

before the Subcommittee on Department Operations, Research, and Foreign Agriculture of the House Committee on Agriculture, Roe told those assembled that the legislation, which Òwould establish a uniform federal system for the review and authorization of releases into the environment of genetically modified organisms,Ó was in response to the Reagan AdministrationÕs ten-year delay in publishing environmental regulations, Òdespite repeated promises.Ó8 2 7

The purpose of the Roe bill

was to provide clear legal authority for EPA and USDA to review the environmental effects of rDNA organisms before granting permits for use in rDNA research or products.

It would accomplish this by

amending TSCA to require a permit for release of rDNA organisms, and create a new statute for USDA that provided permitting requirements modeled on EPAÕs TSCA. An omnibus bill of any kind would be likely to be referred to several Congressional Committees for deliberation.

Whenever there are

multiple referrals, a lot of behind-the-scenes work needs to be done in order to get anything moving legislatively.8 2 8

By using the Clonehead

network, Simon was able to get attention for this bill. 827

Kathy Hudson,

Testimony of Hon. Robert Roe in U.S. Congress, House of Representatives, Committee on Agriculture and Subcommittee on Department Operations Research and Foreign Agriculture, (1990). Review of Current and Proposed Agricultural Biotechnology Regulatory Authority and the Omnibus Biotechnology Act of 1990. U.S. Government Printing Office. Washington, D. C. October 2. Hearing. 101/75. 828 E-mail interview with Lesley Russell, Ph.D. former Congressional staffer for Rep. John Dingell, U.S. House of Representatives Energy and Commerce Committee,

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who worked with Skip Stiles on the Agriculture Committee at the time, remembered SimonÕs strategy: ÒGreg recognized that there was no way he was going to be able to get his own boss [Robert Roe] to be the major spokesperson on this bill. [He knew] that he would have to enlist others to carry the water. He needed the Committees of jurisdiction to hold hearings and [get things moving]. Thus, he encouraged and assisted Committee staff [including Cloneheads] to plan and organize hearings. 8 2 9 At the Congressional hearing on the Omnibus--which was held by George BrownÕs (D-CA) Subcommittee of the Agriculture Committee, not Congressman RoeÕs Science Committee--reactions to the Omnibus, not surprisingly, were diverse.

USDA officials were opposed to the bill,

claiming that the Coordinated Framework was working, APHIS was doing its part, and that the Omnibus would be unnecessarily restrictive. On the other hand, the National Wildlife Federation (NWF), represented by attorney-scientist Margaret Mellon, wanted to Òscrap and replaceÓ the Coordinated Framework with legislation that would give all responsibility for rDNA to the EPA.8 3 0

The NWF felt that the Omnibus

was a step in the right direction, but that amending USDAÕs inadequate Federal Plant Pest Act (See Appendix F) was unacceptable--a whole new

Subcommittee on Oversight and Investigations. Sydney, Australia (March-April, 1999). 829 Interview with Kathy Hudson, Ph.D. former ASM Congressional Fellow, House Agriculture, Research Subcommittee. Washington, DC (December 22, 1997). 830 See Mellon testimony in U.S. Congress, House of Representatives, Committee on Agriculture and Subcommittee on Department Operations Research and Foreign Agriculture, (1990). Review of Current and Proposed Agricultural Biotechnology Regulatory Authority and the Omnibus Biotechnology Act of 1990. U.S. Government Printing Office. Washington, D. C. October 2. Hearing. 101/75.. See especially p.84.

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This negligible support for the Omnibus appears

to be the strongest it ever received from outside Capitol Hill. There were many highly paid lobbyists who would have fought against the Omnibus if they thought it had a chance of becoming law, yet they did not camp on the doorsteps of Congressional representatives.

The White House opposed any process-based

regulation, especially by the EPA, but did not react to the legislation, sensing that the bill would die in committee, as it in fact eventually did. Clearly EPA would have been interested in gaining a stronger authority to regulate rDNA release that the Omnibus would have provided, but predictably, the USDA was not unified in its position, although at an official level it was opposed to the bill. David MacKenzie was asked to draft the USDA position on the Omnibus.

MacKenzieÕs view, as director of the NBIAP, was that risk

studies should be done before claiming that rDNA release would be safe. He wrote in favor of the Omnibus Biotechnology Act, which would have provided a gradual step-wise permitting system to conduct risk assessments, gain information, and apply it to the next experimental level.

However, he claimed that his original position paper was

ÒtrashedÓ by the USDA administrators, although he did not mention names.8 3 1

Terry Medley, who by then had become director of the

Biotechnology, Biologics, and Environmental Protection program in APHIS, still felt that existing statutes were adequate for regulation of rDNA, but he believed that eventually, for commercial products, EPAÕs statutes were better suited to rDNA release oversight because EPAÕs 831

Interview with David MacKenzie, Ph.D. Executive Director, NE Regional Assn of State Agr. Experiment Stations, formerly with CSRS, USDA. Washington, DC

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statutes are risk/benefit statutes, while USDA statutes are aimed at preventing risk.8 3 2

Although Medley did not support additional

legislation, he had provided Simon with suggestions for modifying drafts of the Omnibus.

On the other hand, researchers at USDA felt that

the existing system and the Omnibus were both overly restrictive and scientifically flawed.

For example, in order for rDNA plants to be

regulated under the Federal Plant Pest Act, the most relevant APHIS statute, they had to be defined as plant pests or potential plant pests, otherwise APHIS could not cover them.

The convoluted ways in which

the statutes had to be interpreted in order to force coverage of organisms was scientifically indefensible.8 3 3 Why The Omnibus Failed

The Omnibus was a bill that would never have had a chance of passage during the early Reagan years because his Òno new lawsÓ dictum would have been supported by the Republican Senate.

By 1987,

the entire Congress was back in DemocratsÕ hands and was supported by a network of Cloneheads who believed in Greg SimonÕs legislative approach to rDNA oversight.

SimonÕs bill got some attention on Capitol

Hill, and even had a hearing dedicated to it by the House Agriculture Committee.8 3 4

However, although the Cloneheads had the power to get

favored issues on the agenda, without a strong push from the outside or (December 9, 1997). 832 Interview with Terry L. Medley, J.D. former Director of USDA-BBEP and Administrator of APHIS, USDA. Washington, DC (December 11, 1997). 833 U.S. Congress, House of Representatives, Committee on Agriculture and Subcommittee on Department Operations Research and Foreign Agriculture, (1990). Review of Current and Proposed Agricultural Biotechnology Regulatory Authority and the Omnibus Biotechnology Act of 1990. U.S. Government Printing Office. Washington, D. C. October 2. Hearing. 101/75. 834 Ibid.

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support from more powerful allies, there was not enough interest to get the legislation enacted.

Even a group of dedicated staffers working in

concert can only do so much. The Omnibus Biotechnology Act died in committee, in part because it was an ÒomnibusÓ; that is, it had many parts. Congressional committee jurisdictions. from bill to law is difficult.

It crossed too many

Taking any piece of legislation

Moving a large piece of legislation which

crosses many jurisdictions is very complicated. Another reason for the failure of the Omnibus is that the sponsor of the bill, Congressman Roe, was preoccupied by his projects in public works and was Ònot very interested in science.Ó8 3 5

The Cloneheads who

were on RoeÕs Science Committee were committed to advancing the groundwork in rDNA release policy that was instituted by Al Gore before he left for the U.S. Senate.

The Cloneheads enjoyed working with

biotechnology issues, but when the chairmanship changed and Robert Roe took over, there was little interest in science in general, let alone rDNA.8 3 6

AAAS Fellow, Irene Glowinski, recalled,

ÒRoe cared about highways and infrastructure. He really didn't care about science in general. It wasn't just biotech. That's why I left. I spent 9 months with Roe in charge-doing nothing. I wasn't ready to leave, but I was so bored. We would put together ... hearing charters, ideas, things we wanted to do; and everything got squashed. [Roe] didn't want to do anything [having to do with science].8 3 7 835

Interview with Irene Glowinski, Ph.D. former ACS Congressional Fellow, House Committee on Science and Technology, Subcommittee on Investigation and Oversight. Washington, DC (December 22, 1997). 836 A lack of interest in science on Capitol Hill is the norm. Only when there is a crisis that forces Members to deal with science issues (other than appropriations for research) do staff other than AAAS Fellows or scientific professional staff delve into science issues, and even then it is clearly without enthusiasm. (Personal experience.) 837 Interview with Irene Glowinski, Ph.D. former ACS Congressional Fellow, House

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Even a highly educated scientist can have no impact on science policy if House Committee leadership has no interest in giving her any meaningful work to do.

When Glowinski left, a piece of the brain trust

and the history went with her. Perhaps the most important factor in the death of the Omnibus, and the inability of even a concerted effort by the Cloneheads to change the way the U.S. regulated biotechnology, was simply unfortunate timing. When making political use of an issue that is subject to periodic ebbs and flows, timing is everything.

I offer the view that the primary

reason the Omnibus died in committee, as so many bills do, stems from a lack of public interest, which representatives monitor carefully before acting, because the rDNA Release Era was slowly sliding into a quasiquiescent period.

A quiescent period is not an especially productive

time to introduce powerful comprehensive legislation. By the time the Omnibus was introduced, APHIS had already permitted many field trials, which were proceeding satisfactorily, and APHIS and EPA had been cooperating in the review of rDNA release protocols.8 3 8

The Coordinated Framework, although unable to bring the

controversy to full closure because it never addressed the underlying social and political issues, nevertheless had averted the immediate crisis of public clamor for safety by designating a means of oversight of rDNA research and products in the private sector.

The system was working.

Industry had become accustomed to the complicated regulatory system, Committee on Science and Technology, Subcommittee on Investigation and Oversight. Washington, DC (December 22, 1997). Glowinski actually left RoeÕs Subcommittee staff before the Omnibus Biotechnology Act was introduced. 838 Interview with Terry L. Medley, J.D. former Director of USDA-BBEP and

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and they knew how to Òget around in itÓ so there was no incentive to change it with new legislation.

They knew what to do even though it

was redundant.8 3 9 Without a crisis, there was little general public interest in rDNA release.

Without pressure from the voting public, there was little

incentive for Congress to pursue rDNA issues.

That no biotechnology bill

regarding release of rDNA into the environment ever made it through both houses of Congress, even during crisis/conflict periods, is evidence that rDNA was viewed by the elected officials not as a public crisis, but rather as a convenient political positioning device.

Indicators of Quiescence There were other indicators that quiescence was just around the corner.

First, media attention span plummeted.

The media circus that

was present for the landmark 1987 spraying of Ice-Minus (Frostban) on a strawberry field was nowhere to be found when the rDNA organisms were sprayed on potatoes a few days later by the U.C.-Berkeley team. The Keystone Center, which has a well established reputation for encouraging dialogue on difficult and complex issues involving technological controversy, had discontinued its projects in biotechnology.

The recommendations that came out of a 1989 forum

advocated ideas for administrative changes, but concluded that no new legislation was necessary at the time.8 4 0

Abby Dilley, Associate Director

Administrator of APHIS, USDA. Washington, DC (December 11, 1997). 839 Interview #2 with Shirley Ingebritsen, Senior Regulatory Specialist, APHIS, USDA. Washington, DC (October 2, 1997). 840 Keystone Center, (1989). Keystone National Biotechnology Forum Interim Summary Report: An Analysis of the Federal Framework for Regulating Planned Introductions of Engineered Organisms. The Keystone Center. Keystone, CO. February. Includes a section entitled "Complete Regulatory and NIH Guidelines

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of the Keystone Science and Public Policy Program said, Ò[T]he conclusion of no new legislation was not earth shattering, [but] it was a fairly significant change in the public debate... it's hard for [people] to get excited about no call for immediate action.Ó8 4 1

Dilley also reported

that Keystone activity on these issues dissipated because the issues had faded on the national level, as did financial resources.

Small biotech

companies could scarcely afford to keep up the discussion projects.

Nor

was there an immediate need, because the feeling was that job had been completed.

ÒIronically,Ó Dilley remarked, Òthese issues are coming

back with a vengeance - on a more global scale - and [Keystone is again] involved.Ó8 4 2 Agency activity regarding rDNA release also went into limbo.

EPA

continued to operate under the interim rule on release of rDNA microbial pesticides, and although the ABRAC worked on developing Guidelines for field testing for research,8 4 3 those Guidelines have never officially been promulgated (See chap. 9). Once the Clinton Administration entered the White House, there was no question but that the Release Era of the rDNA debate was over.

The

FDA closed its Office of Biotechnology when Henry Miller was removed from his position, claiming that the office had achieved all its functions. Likewise, in 1996, the USDA closed its Office of Agricultural Biotechnology, proclaiming its Òmission accomplished.Ó8 4 4

Because the

Analysis". See p.4. 841 E-mail interview with Abby P. Dilley, Associate Director, Science and Public Policy Program, Keystone Center. Washington, DC (October 27, 1999). 842 Ibid. 843 Tolin, Sue A. and Anne K. Vidaver, (1989). ÒGuidelines and Regulations for Research with Genetically Modified Organisms: A View From Academe.Ó A n n u a l Review Phytopathology. v. 27 pp. 551-81. See p.567. 844 Office of Agricultural Biotechnology and USDA, (1996). Mission Accomplished:

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official perspective at both FDA and USDA was that biotechnology represented Ònothing newÓ it was contradictory to continue to have such offices.

Summary An intermediate perspective in the rDNA release controversy was the belief that public control equals public confidence in technology.8 4 5 As illustrated by the story of the Capitol Hill Cloneheads, many Congressional Democrats and others with an intermediate perspective on rDNA release favored a legislative approach to oversight.

It was

believed that this participatory approach would assuage public concerns by maximizing public oversight, thus allowing the technology to advance. The Omnibus Biotechnology Act of 1990, written and advocated by a Clonehead, was designed to guide the conservative Coordinated Framework toward a process-based policy that would harmonize to a greater degree with the more environmentally friendly European approach.

I submit that the failure of the Omnibus had more to do with

ill-fated timing than with a lack of concerted effort to make a liberal correction to the path that U.S. biotechnology policy had taken. Congress tends only to react when there is a public crisis.

By the

time Democrats held a majority in both houses of Congress (1987), the rDNA release issue was beginning to enter another quasi-quiescent period.

The Coordinated Framework had been in effect for over three

Final Report of the Office of Agricultural Biotechnology. USDA. Washington, DC. February. Report. 845 By ÔintermediateÕ I mean a view that was midway between that of the conservative scientists and officials who sided with the Reagan AdministrationÕs policy perpective and the social reformer-environmentalists who preferred to

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years, APHIS had been issuing rDNA release permits, and the system was working.

Those who truly wanted to do something with or for

biotech or those who wanted to use the rDNA release debate to further political agenda could not hold the interest of the elected officials any longer, because the crisis period had passed. temporarily become an out-dated issue.

Release of rDNA had

The Omnibus Biotechnology

Act of 1990, which was the last Congressional legislation specifically addressing the release of rDNA into the environment, died in committee and will likely be forgotten.

Yet there are lessons in failures.

It helps

to know what doesnÕt work.

As the Cloneheads found out, trying to

push major legislation during a quiescent period of a controversy does not work.

Unfortunately, such lessons are often visible only in

retrospect. On a positive note, the political correction that the Cloneheads successfully applied to the path of biotechnology policy was to level the playing field for the public to participate in rDNA policymaking.

The

hearings they arranged and their selection of witnesses provided a forum for a wide variety of viewpoints in a democratic, participatory manner.

In addition, the Cloneheads may provide a model for future

Congressional staff initiated caucuses.

It will be especially necessary to

have such educational caucuses as support systems for emerging

abandon rDNA release altogether.

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technologies now that the Congressional Office of Technology Assessment has been disbanded.8 4 6

846

The Congressional Office of Technology Assessment, established in 1972, closed in 1995, a victim of budget streamlining. OTA documents are available at .

PART IV LEARNING FROM THE GENIE

ÒWhere a man stands on an issue depends on where he sits.

847

- Old Capitol Hill Adage

847

This saying supposedly refers to Òwhere a man sitsÓ with regard to the center aisle in the House chamber. Democrats traditionally sit on the SpeakerÕs right and Republicans on the SpeakerÕs left.

CHAPTER TWELVE: PATTERNS IN POLICY MAKING Politically Corrected Science The expression Òpolitically corrected science,Ó as used here, means that politics played a major role in adjusting the incentives and disincentives which modified the trend of rDNA research and development and which forced the technology into alignment with a policy standard that was external to the science itself.

That is, U.S.

biotechnology policy represents a politically motivated ÒcorrectionÓ to the path that rDNA technology research and development may have otherwise taken.

The Federal Coordinated Framework for Regulation

of Biotechnology of 1986, like the RAC Guidelines a decade earlier, succeeded in hastening the decline of concern for safety that was perceived by the general public.

However, again like the Guidelines,

the Coordinated Framework was unable to close the controversy because it did not address the underlying differences in perspective of the participant groups. These underlying social differences are based in an evolving accumulation of personal experiences and fundamental beliefs about the world, which are learned through interactions with families, cultural communities, churches, schools, workplaces, and other social institutions.

These learned personal values, as well as formal

educational experiences, constitute an individualÕs world view.

The

outcome of political conflicts among competing groups in the rDNA controversy depended upon two key factors:

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1 . the world views of those individuals who were in or closest to the most powerful decision making positions (Òhierarchy effectÓ - See Chapter Nine), and 2 . the timing of actions within the political cycle of the debate.

The rDNA Policy Debate Is Political It should come as no surprise that the policy making process on Capitol Hill is political. Why should we expect science policy making to be different from any other policy making process?

Just as

science is not independent of social context, as shown by many STS scholars, neither is science policy.8 4 8 Science, through its technological applications, contributes to political ends and is in turn directed by them.

In biotechnology

controversy, those who believed that rDNA was safe and beneficial attempted to gain control of policy decision making--or at least become very influential in decision making--in order to outmaneuver those who believed that rDNA was n o t safe or beneficial.

Getting into a position of control necessitated playing at

politics. As presented in Chapter Nine, a conservative focus was to develop rDNA into a strong, competitive American technology.

ReaganÕs

preferred mechanism for achieving that goal was to minimize regulation.

Once regulation became inevitable, the preferred

approach was that it should be product-based, not process-based. ÒProduct vs. processÓ was so important and contentious because it went to the very heart of conservative versus liberal politics. 848

For overview and reading lists on this broad topic, see Ziman, John, (1994). An Introduction to Science Studies: The Philosophical and Social Aspects of

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Product regulation is a conservative, traditional approach--the way itÕs always been done. The liberal focus was on building public confidence in rDNA technology so that the social and economic benefits could be realized. This group felt that existing oversight mechanisms were insufficient to assure the public that biotechnology was safe for the environment. They preferred an approach that would recognize the liberal view that rDNA represented a major departure from other life science pursuits.

Process regulation of rDNA was a more liberal concept than

the traditional product regulation, because process regulation of biotechnology invited consideration of other than scientific evidence of risk, such as socioeconomic impacts.

As described in Chapter

Eleven, the Cloneheads, in true Democratic fashion, tried to level the playing field in the debate by including the concerns of groups outside government, industry, and academia.

At the same time,

Democrats continued to work against the Republican Administration to increase public participation and accountability of scientists, w i t h o u t advocating any radical changes to established institutional structures within the government. The radical focus was on revolutionary social and economic reform in order to save the environment and free the working classes from control by corporations.

These groups were forced to argue in terms

of safety because it was the only entrŽe into the debate.

For this

group, the rDNA debate was not about scientific risk, but about mobilizing people for social justice pursuits.

Green political platforms

tend to favor cooperative endeavors toward socially equitable ends, Science and Technology. New York, Cambridge University Press.

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an attitude which stems from an ideology that is rooted in holism and indebtedness to nature.

As exemplified by Jeremy RifkinÕs

campaign (see Chapter Ten), greens are less inclined to trust big business, and tend to be suspicious of technologies which primarily benefit corporations while everyone else accepts the risks.

As

discussed in Chapter Nine, Milewski equated the product versus process distinction with a reductionist versus holistic world view. The greens

represented the most completely holistic perspective.

The liberals and conservatives were still operating under a reductionist philosophy, although liberals gave credence to some holistic viewpoints, such as the importance of protecting the environment. In Chapter Nine, I established the significance of the Òhierarchy effectÓ--the importance of an individualÕs rank in the staffing hierarchy of an agency--on the making of rDNA policy.

The closer a

rDNA debate participant was to the top ranking individual in an agency, the more likely that participantÕs ideas were to be heard by the most important decision makers.

That those high ranking

individualsÕ opinions were heard more frequently by top decision makers had little to do with science and everything to do with political positioning. However, as shown in Chapter Eleven, though a high place in the policy hierarchy may afford immediate power, it is in constant jeopardy either from career assassination by political opponents or from the natural death of an Administration.

The lower civil service

positions are more stable, and are the site of institutional memory. People in these positions can afford to use longer term strategies like

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network building and waiting for the right moment to act.

While

those in high places can strike their political opponents with heavy blows, those in the lower ranks advance their interests using smaller steps, but can do so more enduringly.

For example, The Reagan

Administration effectively prevented any monumental new rules that would single out biotechnology for process regulation, but was ineffective in preventing the EPA from taking the small step of declaring an i n t e r i m policy that would cover all rDNA microbial pesticide research and products, which resulted in a policy that is still in effect in 1999.8 4 9 When several groups used the controversy to vie for political control, the technology fell prey to political correction.

The

directional influence exerted upon science policy, most successfully by the politically best-positioned individuals who based decisions on their own world views, yielded the Òpolitical correctionÓ of this technology. Another purely political consideration in the rDNA debate was peer pressure from fellow scientists to change oneÕs scientific opinion--or to keep silent with unpopular opinions.

For example,

when the studies of enteric bacteria (primarily the laboratory strain of E. coli, K-12 ), emerged from the meetings in Bethesda, MD, (1976) Falmouth, MA (1977), and Ascot, England (1978), and concluded that rDNA was safe, the new facts were things of great value to rDNA proponents.

Although most scientists in the late 1970s appeared to

have closed ranks and to have reached a science-based consensus that rDNA was reasonably safe, there were, even among molecular 849

(49 FR 40659).

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biologists, those who disagreed.

335

Goodell cited multiple sources which

led her to conclude that Ò[The] number of DNA critics [among scientists] indeed decreased, in some cases because they revised their estimates of the safety of the research, but in other cases because they revised their estimates of the safety of speaking out against the research.8 5 0 Public critics became significantly marginalized.

Goodell

documented cases where opponents of rDNA research were cast as Òmystics, hysterics, political opportunists, [and] incompetents.Ó8 5 1 Through interviews with informants who wished to remain anonymous, Goodell learned that some scientists were threatened with having their research grants, jobs, or promotions jeopardized if they had spoken out against the safety consensus.8 5 2

These events

clearly were not purely science-based inputs to the decision making process for science policy, although the facts used to support the actions may have been based in scientific data.

Two opponents can

take the same piece of scientific data and interpret it in contrasting ways.

When Charles Darwin said, ÒEveryone knows how greedily a

theorist pounces on a fact, highly favourable to his views,Ó8 5 3 he might have noted that one of the most frustrating aspects of scientific controversies is that two well respected scientists or groups

850

Goodell, Rae, (1986). ÒHow to Kill a Controversy: The Case of Recombinant DNAÓ in Scientists and Journalists: Reporting Science as News. S. M. Friedman, S. Dunwoody and C. L. Rogers, Eds. New York. The Free Press/Macmillan. pp. 170-181. See p.175. 851 Ibid. 852 Ibid. 853 Charles Darwin, 1846, quoted in an epigraph by Schweber, Sylvan S., (1980). ÒDarwin and the Political Economists: Divergence of Character.Ó Journal of the History of Biology. v. 13 (no. 2) pp. 195-289.

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of scientists might, beginning with the same scientific fact, arrive at exactly opposite conclusions.

I contend that this phenomenon has to

do with the possession by different scientists of differing world views. The presence of knowledgeable scientists on all sides of this ongoing debate provides the strongest evidence that the rDNA controversy is not best represented as a battle between those who understand the science of rDNA and a scientifically illiterate public exhibiting fear of the unknown.

Scientists well versed in the

particulars of molecular biology, including Nobel Prize winners, were inclined in different directions when it came to the appropriate amount of regulatory oversight necessary for rDNA (see Chapter Three).

The rDNA Policy Debate Derives From World View Whenever diverse opinions result from the same starting information, it is probable that something external to the data has influenced paths to conclusions.

I argue that these externalities had

to do with the political expression of personal values, or world view. Thus, a fairly reliable predictor of how a scientist or other rDNA debate participant would view the appropriateness of rDNA technology was not so much his or her understanding of the science behind it as how well the technology fit into his or her personal world view. For example, quite early in the rDNA debate, Erwin Chargaff published an open letter in Science that called for congressional safeguards, not just NIH guidelines, to ensure that an Òirreversible

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attack on the biosphereÓ would not occur.

337

Chargaff, who was no

stranger to molecular biology, framed his position in terms of an ethical problem rather than one of public health.8 5 4

A typically

holistic world view was suggested in his statements that Ò[t]his world is given to us on loanÓ and that the Òfuture will curse usÓ for our Òdestructive colonial warfare against nature.Ó8 5 5

In different

example, former FDA Commissioner, Frank E. Young, who is personally committed to a Christian world view, accepted the manipulation of life using rDNA techniques as an extension of dominion--the Òjob descriptionÓ given to Man by God in Genesis.8 5 6 Young said, ÒAs an extension of dominion and an approximation of truth, science is to be encouraged rather than discouraged.Ó8 5 7 In the introductory chapter, I identified world view as a personal filter through which new information is processed before an individual decides what to believe.

Shared world views, or

ideologies, are outwardly expressed by affiliation with political groups.

Although there are many ideologies and world views, our

political system is dominated by only two political parties. dominant party adequately

If neither

expresses the sentiments of a particular

world view, an individual must either chose the party which most 854

Pre-dating Watson and CrickÕs discovery of the helical structure of DNA, Erwin Chargaff played a significant role in molecular biology by showing that the molecular proportions of the nucleotide bases were constant, in other words, that the amounts of cytosine are equal in proportion to those of guanine, and the amounts of thymine are equal in proportion to those of adenine in all samples of DNA studied. This is known as ÒChargaffÕs Rule.Ó 855 Chargaff, Erwin, (1976). ÒOn the Dangers of Genetic Meddling.Ó S c i e n c e. v. 192 pp. 938-940. 856 Genesis 1:26,28. 857 Interview with Frank E. Young, P. D. M.D. former Commissioner, U.S. Food and Drug Administration. Washington, DC (December 18, 1997). Young has retired from government and is now working as an adult ministries counselor.

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closely represents his or her ideology, or seek an alternative pathway (like membership in an activist group). Although selection of political party may represent the Òbest fitÓ of an outward expression of world view, there is no guarantee of congruence.

Very few people support every single platform position

of political parties that they support generally.

In the rDNA debate,

some academics, typically Democrats, supported Republican efforts to preserve the ability of industry to blossom--after all, some of them had their own companies on the side (for example, Winston Brill).

On

the other hand, a self-described consummate Republican, Bernadine Healy, designed the super RAC--a bureaucratic nightmare of a structure with built-in public participation. Because sustainability and the green lifestyle message are more important than political success, the concept of a Green Party Òis in itself a contradiction, yet greens [had] no other vehicle for the expression of their [ideology].Ó8 5 8

Because the Green Party has not

yet enjoyed a dominant position in the U.S., adherents to its principles have had to use strategies outside of established institutional structures in order to have their opinions on rDNA heard.

Jeremy Rifkin in particular made use of the rDNA debate as a

platform from which to preach his own green world view recommendations.8 5 9

858

Franklin, Martin, (1992). ÒBook Review: Green Party Members: a Profile Green Politics Research Group Reports No. 1, by Wolfgang Rudig, Lynn G. Bennie, Mark L. Franklin; [Delta Publications].Ó Political Quarterly. v. 63 (3) (July-September) pp. 364-366. See p.366. 859 ÒRecommending a world-view is what politicians and preachers do.Ó See p.32 in Knight, David, (1992). Ideas in Chemistry. New Brunswick, NJ, Rutgers University Press.

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By detailing the social history of the development of U.S. agricultural biotechnology policy, I have shown that various groups of people with shared world views (ideologies) competed to make the policy for this new technology fit into their ideological perspectives. For example, those with the shared world view best expressed as green politics challenged many uses of rDNA technology, because it represented an affront to their belief in the holistic nature of nature, or the rights of organisms to an unviolated species integrity, or the rights of the public not to feel controlled by strong members of an opposing ideology.

Placing control of rDNA in the hands of big

corporations and what they perceived to be an inadequate government made them feel vulnerable (see Chapter Ten). The Reagan Administration, on the other hand, wanted to leave the powerful technology in the unfettered hands of the universities and companies who could develop it into a powerful international competitive advantage for the U.S.

The Administration had rDNA

proponents in key positions of agencies that maintained a Òno new rulesÓ approach to biotechnology oversight (see Chapter Nine). An intermediate perspective in the rDNA release controversy, between that of the scientists and officials who sided with the Reagan AdministrationÕs policy perspective and that of the social reformer-environmentalists, was the belief that public control promotes public confidence in technology.

Congressional Democrats

worked in cooperation with the EPA in an attempt to expand public involvement, accountability, and oversight of rDNA environmental releases.

This was all viewed as necessary to allow the important

technology to advance.

As illustrated by the story of the Capitol Hill

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Cloneheads (Chapter Eleven), many Congressional Democrats and others with an intermediate perspective on rDNA release favored a legislative approach to oversight.

Among those who shared the

perspective that building public confidence in the technology through appropriate regulation was the key to advancing the technology were Elizabeth Milewski (first of the NIH, then of the EPA) and Terry Medley of USDAÕs Office of General Counsel. As new information about rDNA is revealed, and as personal and political environments change, world views in most cases can be expected to evolve.

Even Jeremy Rifkin has evolved from being an

absolute opponent of biotechnology to admitting that it had some benefits.8 6 0

One of the Cloneheads, Kathy Hudson, who moved to a

leadership position in the NIH, said the following about the CloneheadsÕ choice of means to a goal: ÒOf course, we were working for the Congress which exerts its influence through the legislative process. Thus, we used the tools and processes available to us. Now that I sit in the Executive Branch I don't always think that way.8 6 1 With her new career came a modification to her world view, her ideological goals, and her preferred means of attaining those goals. Contrast RifkinÕs and HudsonÕs evolving world views with that of the conservative Henry Miller, who appears not to have evolved at all

860

Crossfire with Tom Braden and Bob Novak (1987). John Fulkerson, USDA, versus Jeremy Rifkin, FET. CNN-TV. April 20. Washington, D.C. 861 Interview with Kathy Hudson, Ph.D. former ASM Congressional Fellow, House Agriculture, Research Subcommittee. Washington, DC (December 22, 1997).

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from his original position, despite major career changes, as exemplified by his most recent book on the rDNA debate.8 6 2

The rDNA Policy Debate Is Periodic Evolution of world views and changes in political milieu contribute to a characteristic of the rDNA debate called periodicity.

As

introduced in Chapter One, Fletcher concluded in his study of the human gene therapy debate that ethical controversies go through a single cycle of four stages: threshold, open conflict, extended debate, and adaptation.8 6 3

I have shown that FletcherÕs stages (renamed

gestation, threshold, crisis/conflict, and quasi-quiescence) are operating not only on the relatively large, two-decade time scale that he presents for human gene therapy (1967 through 1990), but also on multiple, smaller time scales for other subsets of the rDNA debate. In addition, these periods are fluid, overlapping, and repetitive, as I will summarize here. During the long period before the threshold of the Containment Era, agricultural researchers such as Smith/Townsend and Barbara McClintock conducted their observations of what was later determined to be recombinant activities in the open fields, without public interference (Chapter Two).

In Chapter Three, I reviewed the

rest of the periods of the Containment Era.

The publication in Science

of the Singer-Soll and Berg letters (1973 and 1974) marked a public threshold of interest in rDNA.

862

A self-imposed moratorium on

Miller, Henry I., (1997). Policy Controversy in Biotechnology: An Insider's V i e w. Austin, R.G.Landes Co. 863 Fletcher, John C., (1990). ÒEvolution of Ethical Debate about Human Gene Therapy.Ó Human Gene Therapy. v. 1 (1) (Spring) pp. 55-68.

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research provoked a perceived safety crisis which resulted in a conflict among scientists and others about whether and how much regulation of rDNA research was necessary.

The U.S. government

took action in the form of establishing the RAC, which in turn promulgated research Guidelines for containment of rDNA organisms so that research could continue.

This action resulted in a debate

resolution illusion so convincing that at least two authors supposed that the controversy over rDNA had ended.8 6 4

I call this the first

quasi-quiescent period, because there was a new Era gestating at the same time. In Chapter Four I described how the USDA scientific community made a concerted effort to change the RAC Guidelines to accommodate research needs beyond biomedical purposes.

As an

advisory panel, the RAC had no official authority from the Congress to regulate anything, but as the only de facto regulator of rDNA technology, it began to experience great pressure as the industry grew, biomedical research moved into the development phase, and agriculture began to make demands for changes in prohibitions against environmental release of rDNA (Chapter Five).

The debate

burst through the 1983 threshold into a crisis period of the controversy in the wake of Diamond v. Chakrabarty, and the approval of several requests to take rDNA outdoors--especially the 864

Wright, Susan, (1986). ÒMolecular Biology or Molecular Politics? The Production of Scientific Consensus on the Hazards of Recombinant DNA Technology.Ó Social Studies of Science. v. 16 pp. 593-620.; Wright, Susan, (1994). Molecular Politics: Developing American and British Policy for Genetic Engineering, 1972-1982. Chicago, University of Chicago Press.; Goodell, Rae, (1986). ÒHow to Kill a Controversy: The Case of Recombinant DNAÓ in S c i e n t i s t s and Journalists: Reporting Science as News. S. M. Friedman, S. Dunwoody and C. L. Rogers, Eds. New York. The Free Press/Macmillan. pp. 170-181..

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1983 final RAC approval of Ice-Minus microbial pesticide (Chapter Six).

Washington insiders began to use rDNA as a rallying device and

moved into polarized camps for the ensuing conflict (Chapter Seven). Chapter Eight describes how in a single year during the height of the Release Era crisis/conflict period (1984), the USDA went through its own micro-version of all the periods of the rDNA controversy cycle.

Trouble was brewing in the fall of 1983 and winter months of

1984 when the EPA appeared to step on the regulatory toes of APHIS.

By spring, a threshold was crossed when APHIS and ARS

within the USDA broke ranks with the CSRS and considered regulation as an option.

Pressure from three different political

perspectives threw the USDA into internal conflict during the summer months:

Jeremy Rifkin had won his lawsuit against release

of the Ice-Minus bacteria; the Democrats in the House of Representatives had ordered an audit of the Department because of perceived inattention to rDNA affairs; and the Reagan Administration was still demanding the A-RAC to provide regulatory statements for the Coordinated Framework.

Finally, the agencies were drawn

together in late autumn 1984, not by philosophical consensus, but by a need to protect the DepartmentÕs regulatory interests and the research it supported from a common competitor--the EPA.

Thus,

the quasi-quiescent micro-period for the USDA was characterized not by a consensus on regulation of rDNA, but by an illusion of resolution as USDA finally issued a unified statement for the 1984 proposed Coordinated Framework that it would participate in the regulation of rDNA.

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The great differences in world view of participants in this debate were most obvious during the 1980s crisis/conflict period of the Release Era.

The conservative Reagan Administration had the power

to protect rDNA so it could advance business interests by sticking to a Òno new rulesÓ policy (Chapter Nine).

The Administration

responded to public demands for protection from the hazards of rDNA by establishing the Federal Coordinated Framework for Regulation of Biotechnology, a compromise which required no new laws, but used existing statutes to regulated rDNA technology as though it were nothing new or unusual.8 6 5 In Chapter Eleven I reconstructed the little known activities of a group of Congressional aides known as the Cloneheads, whose efforts toward fixing the Coordinated Framework included giving it a more participatory character--publicly and jurisdictionally.

Intermediate

in political perspective between the conservatives and the radicals, those with a liberal ideology wanted more public oversight of rDNA affairs without giving up the established institutional structures of the federal government, in which they held a major interest. Meanwhile, on the outside of the dominant institutional structure, trying to promote a lifestyle that did not include biotechnology or government control by an elite class of corporate stockholders, was green world view advocate, Jeremy Rifkin, a member of the New Left Movement generation (Chapter Ten).

Despite predictions of doom,

Rifkin did not f e a r rDNA. He u s e d it to deliver his green political 865

Office of Science and Technology Policy, Executive Office of the President. (1986). ÒCoordinated Framework for Regulation of Biotechnology; Announcement of Policy and Notice for Public Comment.Ó Federal Register v. 51: 23302-23350. June 26.

Chapter 12 message.


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Until he can garner enough support for political reform

from sufficient numbers of people to put pressure on high ranking decision makers, Rifkin must rely on keeping the debate in a crisis/conflict period as long as possible.

However, he runs the risk

of having his message co-opted and diluted by Democrats who only seem to need his environmental, participatory rhetoric when they are not in power. For example, a minor pattern that emerges from this study, which links periodicity to the politics of rDNA technology, is that the quasiquiescent period of the Containment Era (from 1977-1981) was one of only two times during the history of biotechnology that there was a unified Democratic Party control of the U.S. federal government.8 6 6 In 1993-1994, the Democratic Party again controlled both the Executive Branch and both houses of the Legislature.

In 1994, the

Biotechnology Industry Organization discontinued publishing its yearly surveys of state and federal legislation related to biotechnology because it had Òceased to be a pressing issue,Ó indicating a relaxed period of adaptation had been reached.8 6 7 Each quasi-quiescent period was in synchrony with a federal government completely controlled by Democrats.

One must wonder whether this

is merely a coincidence. An analysis of two phases of the rDNA environmental release controversy indicates that the most effective time for taking policy action is during the crisis/conflict period in response to a perceived 866

Thurber, James A., (1996). Rivals for Power. Washington, DC, Congressional Quarterly. 867 Telephone interview with Raymond Briscuso Jr., J.D. Executive Director, Biotechnology Industry Organization. Washington, DC 1996).

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public crisis--provided there is sufficient political power behind the action.

The Reagan AdministrationÕs timing in promulgating the

Coordinated Framework (1986) worked well.

In that year,

conservatives held the most power over policy decision making for rDNA.

The Administration, the U.S. Senate, and major participants in

the agencies responsible for coordinating the oversight effort were mostly of a conservative ideology with respect to rDNA.

Because the

debate was still in a crisis period when action was taken, their Coordinated Framework effort was successful. In contrast, the patient, wait-and-see strategy of the USDAÕs CSRS during the early development of the Coordinated Framework (1984) was a poor timing choice because they were waiting-and-seeing right in the middle of the Release Era crisis period, when the public was demanding action.

CSRS was trying to hold the line on regulation

until the RAC could be equipped to handle agricultural releases, hoping that the Congressional and public attention spans would expire, as they inevitably did, before regulations became mandatory (See Chapters Seven and Eight).

Jeremy Rifkin was not about to let

that happen (see Chapter Ten).

Unfortunately, the decision to stall

for time during a crisis period made the USDA look stubborn, or indecisive, not patient. There was another victim of poor timing, as described in Chapter Eleven.

The Omnibus Biotechnology Act was not advocated until

after the rDNA controversy was declining into a quasi-quiescent period.

That bill would not have had a chance of passage during the

crisis/conflict period (mid-1980s) because Republicans controlled the U.S. Senate at the time.

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Although the Democrats were in control of both houses of Congress in 1990 (good timing for a Democrat-led initiative), the Omnibus Biotechnology Act of 1990 failed to generate enough public attention for passage because the debate was already slipping into another quasi-quiescent period following the AdministrationÕs action in promulgating the Coordinated Framework (poor timing because the crisis had passed).

In other words, it was necessary to have had

both timing factors occur in conjunction in order to facilitate success of any rDNA action. his favor.

ReaganÕs action came when both factors were in

The Cloneheads did not have that fortune.

In politics,

timing is everything. Like some of the strategies of the various players in the controversy, rDNA technology itself may have been a victim of poor timing.

The concurrent information technology revolution, which

helped molecular biologists to learn more about rDNA more quickly, has also provided the means for spreading anti-biotechnology messages.

In an age when dissemination of information is

instantaneous, (often before it is confirmed) it behooves policymakers to consider public opinion in the formula.

Final Thoughts This political model of the rDNA controversy serves as a tool with which to order the participants in the rDNA debate, not with respect to their scientific credentials or their understanding of the relative risk of using rDNA versus traditionally produced products, but with respect to their world views, as expressed by group affiliations.

My

analysis of the rDNA debate is strengthened by the similar findings

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of Jasper, who concluded that the public took the side of the nuclear controversy that was compatible with existing values and beliefs.

In

addition, Jasper cited several public surveys that supported the conclusion that in highly politicized debates about nuclear power, peopleÕs basic values (i.e., world views) were excellent predictors of attitudes toward the technology.8 6 8

Jasper also noted that in France,

when socialists came to power and gave government posts to activists, a Òsocialist nuclear program was more tolerable than the conservative program had been.Ó8 6 9 This social history of the development of U.S. agricultural biotechnology policy helps to explain how and why the Coordinated Framework came to be.

It is hoped that having a better

understanding of the influence of world views on public decision making can help scientists to take account of non-scientific views. Scientists can then appropriately incorporate this understanding into scientific advice to policy makers. This study also furnishes patterns to look for in the political milieu of the continuing rDNA controversy.

As a technology totally

immersed in politics, rDNA is as dependent upon the outcomes of national elections and the composition of federal advisory panels as it is dependent upon an influx of bright new scientists.

We are

currently experiencing a renewed crisis/conflict period in the Global Era of debate about agricultural biotechnology.

With an approaching

national election, biotech companies must remain flexible and ready to work in any political environment. 868

Careful analysis of world view

Jasper, James M., (1988). ÒThe Political Life Cycle of Technological Controversies.Ó Social Forces. v. 67 (2) (December) pp. 357-377. See p.357-368.

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trends, outward expression of those views by those who might attain positions of power over rDNA policy decision making, and the probability that important timing factors will occur in conjunction must be considered in making long-term business decisions. Stubborn adherence to tradition may not work if the rest of the world is evolving in its world view.

869

Ibid.

See p.363.

350

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375 Uncited author, (date of posting not given). ÒMembers of the Supreme Court of the United StatesÓ. Accessed July 29, 1999. Unger, Irwin, (1974). The Movement: A History of the American New Left, 1959-1972. New York, Dodd, Mead & Co. Wade, Nicholas, (1980). ÒCourt Says Lab-Made Life Can Be Patented.Ó Science. v. 208 (June 27) p. 1445. Wald, George, (1976). ÒThe Case Against Genetic Engineering.Ó T h e Sciences. v. 16 (September) p. 6+. Watson, James D., (1977). ÒAn Imaginary Monster.Ó Bulletin of the Atomic Scientists. v. 33 (May) p. 12+. Watson, James D., (1980). The Double Helix: A Personal Account of the Discovery of the Structure of DNA. New York, Norton & Company. Watson, J.D. and F.H.C. Crick, (1953). ÒMolecular Structure of Nucleic Acid: A Structure for Deoxyribose Nucleic Acid.Ó Nature. v. 171 pp. 737-738. Watson, James D. and John Tooze, (1981). The DNA Story: A Documentary History of Gene Cloning. San Francisco, W. H. Freeman and Company. Wildavsky, Aaron, (1988). Goldilocks is Wrong: In regulation of biotechnology, only the extremes can be correct. preprint. Political Science. University of California. Berkeley, CA. Worth, Gretchen, (1985). ÒMaking Snow While the Sun Shines: Out of the Lab and onto the Slopes.Ó Working Woman. v. (April) p. 78. Wright, Susan, (1986). ÒMolecular Biology or Molecular Politics? The Production of Scientific Consensus on the Hazards of Recombinant DNA Technology.Ó Social Studies of Science. v. 16 pp. 593-620.

376 Wright, Susan, (1994). Molecular Politics: Developing American and British Policy for Genetic Engineering, 1972-1982. Chicago, University of Chicago Press. Yesley, Michael S., (1992). Bibliography: Ethical, Legal, and Social Implications of the Human Genome Project. Washington, DC, U.S. Department of Energy, Office of Energy Research. Zilinskas, Raymond A. and Burke K. Zimmerman, Eds. (1986). The GeneSplicing Wars: Reflections on the Recombinant DNA Controversy. Issues in Science and Technology Series; American Association for the Advancement of Science. New York, MacMillan Publishing Company. Ziman, John, (1994). An Introduction to Science Studies: The Philosophical and Social Aspects of Science and Technology. New York, Cambridge University Press.

APPENDICES

378

APPENDIX A LIST OF INTERVIEWED SUBJECTS Note: The following people are gratefully acknowledged as having contributed significantly to this work. They have all submitted to interviews of varying lengths--in person, by telephone, by electronic mail, or in some cases all three means of communication. In addition, each has reviewed relevant parts of the text and has given valuable advice for changes. Although I accept full responsibility for any errors, I am indebted to each of them and thankful for their obvious interest in the project.

John Cohrssen, J.D. former legal counsel, Cabinet Council Working Group on Biotechnology, Reagan Administration. Robert M. Cook-Deegan, M.D., formerly at the Office of Technology Assessment. Abby P. Dilley, Associate Director, Science and Public Policy Program, Keystone Center. David Espeseth, D.V.M., Director, Veterinary Services, APHIS, USDA. Eric Flamm, Ph.D. Senior Policy Advisor to the Deputy Commissioner for Policy, U.S. Food and Drug Administration. Arnold Foudin, Ph.D. APHIS, USDA.

Deputy Director Biotechnology Permits, PPQ,

Val Giddings, Ph.D. formerly with Office of Technology Assessment; presently with Biotechnology Industry Organization. Irene Glowinski, Ph.D. former ACS Congressional Fellow, House Committee on Science and Technology, Subcommittee on Investigation and Oversight. Kathy Hudson, Ph.D. former ASM Congressional Fellow, House Agriculture, Research Subcommittee. Shirley Ingebritsen,

Senior Regulatory Specialist, USDA-APHIS.

David T. Kingsbury, Ph.D. former Assistant Director, Biological, Behavioral, and Social Sciences, National Science Foundation.

379 David MacKenzie, Ph.D. Executive Director, NE Regional Assn of State Agr. Experiment Stations, formerly with CSRS-USDA. Terry L. Medley, J.D. former Director of BBEP and former Administrator of APHIS, USDA. Kathleen Merrigan, former Congressional staffer for Patrick Leahy (DVT), Senate Agriculture Committee. Elizabeth Milewski, Ph.D. formerly on staff at NIH-ORDA, presently Special Assistant for Biotechnology, EPA. L. Christopher Plein, Ph.D. Assistant Professor of Public Administration, West Virginia University. Lesley Russell, Ph.D. former Congressional staffer for Rep. John Dingell, U.S. House of Representatives Energy and Commerce Committee, Subcommittee on Oversight and Investigations. William (Skip) Stiles, Senior Staff, U.S. House of Representatives, Committee on Science; formerly on staff of House Agriculture Committee. Sue A. Tolin, Ph.D. Professor of Plant Pathology, Physiology, and Weed Science, Virginia Polytechnic Institute and State University. Former USDA Representative to the RAC and to OECD. Alvin L. Young, Ph.D. former Director, Office of Agricultural Biotechnology, USDA, and Executive Secretary of the ABRAC, USDA. Frank E. Young, M.D. Ph.D., former Commissioner, U.S. Food and Drug Administration. ***** I also wish to thank the following people for helping me to clarify details: Raymond Briscuso, J.D.; M. Rupert Cutler, Ph.D.; Ronald W. Davis, Ph.D.; Raymond Dobert, Ph.D.; Sheldon Krimsky, Ph.D.; Becky Lawson; Ferdinand Mack, J.D.; Stuart Newman, Ph.D.; Jane Setlow, Ph.D.; A n d r e w S. Wright, J.D.

380

Appendix B Membership, Joint Council Recombinant DNA Committee (JCRC) (October 10, 1978)8 7 0 Clarence Grogan - USDA-SEA-CR Mary Clutter - NSF Stanley Krugman - USDA-Forest Service William Gartland - NIH-ORDA Charles F. Lewis - USDA-SEA Robert Kahn - USDA-APHIS Joe L. Key - USDA - SEA Peter Day - Department Head, Genetics, Connecticut Agricultural Experiment Station

Membership, Joint Council Recombinant DNA Committee (JCRC) (circa 1979)8 7 1 Clarence Grogan - USDA-SEA-CR David W. Krogmann - USDA-SEA-CGRO Mary Clutter - NSF Stanley Krugman - USDA-Forest Service William Gartland - NIH-ORDA Gerald Still - USDA-SEA-AR Robert Kahn - USDA-APHIS Sue A. Tolin - Associate Professor, Plant Pathology, Virginia Tech Note: Another undated membership list identical to the JCRC (circa 1979) list appears with the items ÔJoint CouncilÕ and Ô(JCRC)Õ stricken and ÔUSDAÕ written above the stricken ÔJoint CouncilÕ. One additional name is on this particular copy of the list: Holly Schauer from USDA Competitive Grants Office . 8 7 2

870

List attached to letter from James Nielson, Executive Director, Joint Council on Food and Agricultural Sciences, to Members of [Agricultural] Recombinant DNA Committee, dated October 10, 1978. Tolin Archive, Box #4, Folder: FKN-114. 871 Undated list, Tolin Archive, Box #2, Folder: JCRC 1979. 872 Undated list, Tolin Archive, Box #4, Folder: FKN-111

381

Appendix C Voting Record of Supreme Court Justices in Diamond v. Chakrabarty , Decided June 16, 19808 7 3

Justice Chief Burger Stewart Blackmun Rehnquist Stevens

Vote For * For * For * For * For *

Appointed by Nixon Eisenhower Nixon Nixon Ford

PresidentÕs Republican Republican Republican Republican Republican

Br e n nan White Marshall Powell

Against Against Against Against

Eisenhower Kennedy Johnson Nixon

Republican Democrat Democrat Republican

Party

*ÔForÕ indicates in ChakrabartyÕs favor, i.e., that his bacterium was patentable. Sydney A. Diamond was the Commissioner of Patents and Trademarks from 1979-1981 under Democratic President Jimmy Carter.8 7 4 873

Diamond v. Chakrabarty, U.S. Supreme Court Opinion No. 79-136. Chief Justice Burger delivered the opinion of the Court. A dissenting opinion was written by Mr. Justice Brennan. This chart was compiled from information available at: Uncited author, (date of posting not given). ÒMembers of the Supreme Court of the United StatesÓ. Accessed J u l y 29, 1999 . 874 U.S. Department of Commerce, (1988). The Story of the U.S. Patent and Trademark Office. Washington DC, Department of Commerce.

382

Appendix D ÒThe Environmental Implications of Genetic EngineeringÓ8 7 5 III. Recommendations The following recommendations are based on the findings outlined above [in the Summary of the ÒGore ReportÓ]: (1.) The EPA should proceed with its stated intention to extend its authority to include all deliberately released organisms not specifically identified as part of the legal obligation of another agency. In view of EPAÕs stated conclusion that the Toxic Substances Control Act (TSCA) does not provide it with authority to oversee deliberate releases and the fact that Congress intended TSCA to be Ògap fillingÓ legislation, no additional legislation or clarifying amendments are needed at this time. EPA should, however, establish formal communications and agreements with other agencies to ensure that gaps and redundancies in the regulatory structure do not occur. A major goal should be to permit research and commercialization to proceed with minimum interference while adequately addressing environmental and public health concerns. (2.) Until such time as EPAÕs regulations are promulgated, an interagency task force should be established to review all proposals for deliberate releases. EPA should take the initiative in organizing this panel. The panel should be comprised of representatives from EPA, USDA, NIH, and any other appropriate federal agency or entity directly involved from either the scientific or regulatory perspective. The panel should establish an environmentally oriented risk/benefit assessment program to evaluate current proposals for deliberate releases and to provide a data base for decisions on future releases. The panel should also develop a uniform set of guidelines to govern deliberate releases. The panel should, moreover, serve the function of educating the public about the potential risks and benefits associated with this aspect of biotechnology. Consideration should be given to making this panel a permanent 875

U.S. Congress, House of Representatives, Committee on Science and Technology, Subcommittee on Investigations and Oversight, (1984). The Environmental Implications of Genetic Engineering (The "Gore Report"). U.S. Government Printing Office. Washington, D. C. February. Staff Report. Serial V. Pages 11 and 12 are reproduced here. The summarized recommendations are also reprinted in (49 FR 17682), April 24, 1984.

383 oversight body even after EPA has promulgated regulations to ensure that the broadest possible expertise is brought to bear in overseeing the technology. (3.) No deliberate release should be permitted by EPA, NIH, USDA, or any other federal agency until the potential environmental effects of the particular release have been considered by the interagency review panel. The panel shall consider the effects of any environmental release, regardless of size or intent. Each agency should evaluate proposals for deliberate releases according to a uniform set of guidelines to be developed by the interagency task force. It is recognized that initially decisions may be made on the basis of incomplete data. (4.) The task force should consider the need for oversight of research scale releases and, if appropriate, develop guidelines for reviewing proposals for such releases. The task force should prepare a report containing its conclusions on this matter within 90 days of its establishment. The report should be made available to the Subcommittee. (5.) The NIH should cease its practice of evaluating and approving proposals for deliberate releases from commercial biotechnology companies. The NIH should review proposals only from parties engaged in NIH-sponsored research, and refer requests from industry to the appropriate agency. (6.) The NIH and USDA should revise the membership of their respective Recombinant DNA Advisory Committees (RAC) to include individuals specifically trained in ecology and the environmental sciences. (7.) The General Accounting Office should review the activities of USDA in overseeing biotechnology and evaluate the agencyÕs authority to regulate deliberate releases under all relevant statutes, regulations, and executive orders.

384

Appendix E RAC Working Group on Release into the Environment Membership List of Spring, 1984.8 7 6 McGarity, Gerard J., Ph.D. - Department of Microbiology, Institute for Medical Research (Working Group Chairman) Arntzen, Charles, Ph.D. - Plant Research Laboratory, Michigan State U. Clowes, Royston C., Ph.D. - Division of Biology, Univ. Texas at Dallas Fowle, John R., Ph.D. - Liaison, EPA Office of Research and Development Gartland, William J., Jr., Ph.D. - RAC Executive Secretary, ORDA, NIH Gottesman, Susan K., Ph.D. - Laboratory of Molecular Biology, National Cancer Institute, NIH Lacy, George, Ph.D. - Department of Plant Pathology, Physiology, and Weed Science, Virginia Tech Miller, Henry I., M.D. - Liaison, Office of Biologics, Food and Drug Admin. Mitchell, Robert E., LLB - Attorney at Law, Norwalk California Pimentel, David, Ph.D. - Department of Entomology, Cornell University Pirone, Thomas P., Ph.D. - Department of Plant Pathology, U. of Kentucky Scandalios, John G., Ph.D. - Department of Genetics, North Carolina State U. Sharples, Frances E., Ph.D. - Program, Planning, and Analysis Office, Oak Ridge National Laboratory Tolin, Sue A., Ph.D. - Liaison, CSRS, Science and Education Admin., USDA 876

Source: Minutes of the RAC Release Working Group, April 9, 1984.

385

Appendix F Major Federal Measures Having Relevance to the Release of rDNA into the Environment NEPA The National Environmental Policy Act (NEPA) of 1969 requires all federal agencies to consider the potential environmental effects of their regulations and actions.

NEPA created the Council on Environmental

Quality in the Executive Office of the President, which in turn required all agencies to prepare environmental impact statements on major Federal actions significantly affecting the environment.8 7 7 Most of Jeremy RifkinÕs lawsuits were based on agenciesÕ lack of compliance with NEPA. The RAC Guidelines For many years, the NIH Guidelines represented the only federal oversight of rDNA. research.

They were designed for basic laboratory rDNA

Although the Guidelines were highly regarded, they did not

arise from a law.

A major limitation was that the only sanction for non-

compliance was withdrawal of federal funding.

Nevertheless, the

private sector complied voluntarily, and the RAC continued, reluctantly, to review proposed environmental releases of rDNA throughout the 1 9 8 0 s .8 7 8 877

Public Law 91-190; 42 USC ¤4321 et seq. For an overview of NEPA, see Lidsky, Michael Alan, (1986). The Potential Challenges Facing USDA in Regulating the Release of Genetically Engineered Organisms Under the Federal Plant Pest Act. Master's Thesis. National Law Center. The George Washington University. Washington, DC. or http://www.webcom.com/~staber/nepa.html. Lidsky relates NEPA directly to biotechnology. The website is more general. 878 Keystone Center, (1989). Keystone National Biotechnology Forum Interim Summary Report: An Analysis of the Federal Framework for Regulating Planned

386

FDCA The FDA used the authority given to it by the Food, Drug and Cosmetic Act (FDCA) to oversee the production of rDNA drugs, diagnostic kits, and food additives.8 7 9

However, unprocessed food products,

including rDNA derived products, are not examined unless a problem is discovered.

FDCA allows for post-market authority for foods, pre-

market authority for drugs.

No reinterpretation of this statute was

considered to accommodate products of rDNA because the regulations were already considered very rigorous. VSTA, PQA, and FPPA USDA had three statutes relevant to the release of rDNA organisms into the environment--if one includes the use of live-virus vaccines as an environmental release.

Animal vaccines, including rDNA derived

vaccines, would be licensed under the Virus Serum Toxin Act (VSTA), first passed in 1913.8 8 0

The Plant Quarantine Act (PQA) of 1912 was

designed to protect American agriculture from the importation of insect pests and plant diseases.8 8 1

The Federal Plant Pest Act (FPPA) of 1957

provided the Secretary of USDA the ability to take emergency action against those who would move plants infested with pests into the country or between states.8 8 2 All three statutes, VSTA, FPPA, and PQA, were enacted before biotechnology became a reality, and all have to do with the m o v e m e n t Introductions of Engineered Organisms. The Keystone Center. Keystone, CO. February. Includes a section entitled "Complete Regulatory and NIH Guidelines Analysis". See p.9. 879 Food Drug and Cosmetic Act (21 USC ¤301 et seq.) 880 Virus Serum Toxin Act (21 USC ¤151 et seq.). 881 Plant Quarantine Act (7 USC ¤154 et seq. as amended) 882 Federal Plant Pest Act (7 USC ¤150 et seq.)

387 of organisms or biologicals, not how they are made.

Both PQA and FPPA

limit the SecretaryÕs authority to take action only in cases where the pests are Ònew to and not theretofore known to be widely prevalent or distributed within and throughout the United states.Ó8 8 3

The definition

of ÔnewnessÕ became a key issue at USDA as well as at EPA. In 1985, VSTA was amended to give it the power to include regulation of i n t r a s t a t e movement of biologicals (such as veterinary vaccines) if state oversight were deemed inadequate. FIFRA and TSCA The agency with the most obvious mandate to protect broad environmental interests is the EPA.

Its statutes, the Federal Insecticide,

Fungicide and Rodenticide Act (FIFRA) and the Toxic Substances Control Act (TSCA) were designed to protect human health and the environment from indiscriminate use of pesticides and toxic chemicals.8 8 4 FIFRA only provides authority over products defined as pesticides. Under FIFRA, a product must be preregistered with the EPA along with data to show that the benefits of using the pesticide will outweigh its risks.8 8 5

Like the USDA statutes, both FIFRA and TSCA required artful

reinterpretation of legal definitions in order to become applicable to products of biotechnology.

For example, in order to regulate Ice-Minus

under FIFRA, a living, ice-nucleation deficient organism had to be 883

7 USC ¤150 dd(a). For a review of the shortcomings of both PQA and FPPA in regulating biotechnology, see Lidsky, Michael Alan, (1986). The Potential Challenges Facing USDA in Regulating the Release of Genetically Engineered Organisms Under the Federal Plant Pest Act. Master's Thesis. National Law Center. The George Washington University. Washington, DC. Also, Fanning, David W., (1988). Issues Raised by Biotechnology: A Keystone Biotechnology Discussion P a p e r. The Keystone Center. Keystone, CO. July 14. See p. 9. 884 FIFRA is at 7 USC ¤136 et seq. TSCA is at 15 USC ¤2601 et seq. 885 McGarity, Thomas O., (1985). ÒRegulating Biotechnology.Ó Issues in Science and

388 defined as a pesticide, while the wild type ice-nucleating bacteria of the same species was cast in the role of the Òpest.Ó Like FIFRA, TSCA was designed with inanimate chemical compounds and not living organisms in mind.

Like FIFRA, TSCA requires

premanufacturing notification to the EPA, which then has the burden of proof for determining whether or not the product is hazardous.8 8 6 The most controversial aspect of using TSCA to regulate rDNA was the need to redefine DNA as a ÒchemicalÓ and rDNA products as Ònew chemicalsÓ in order to stretch the law to cover biotechnology.8 8 7

T e c h n o l o g y. v. 1 (no. 3 Spring) pp. 40-56. 886 Fanning, David W., (1988). Issues Raised by Biotechnology: A Keystone Biotechnology Discussion Paper. The Keystone Center. Keystone, CO. July 14. p.12. 887 Ibid. See p.11, 13.

See

389

Appendix G The Biotechnology Science Coordinating Committee (BSCC)8 8 8 Chairman: David T. Kingsbury Assistant Director for Biological, Behavioral, and Social Sciences National Science Foundation Orville Bentley Assistant Secretary for Science and Education, USDA Alan Tracy Acting Assistant Secretary for Marketing and Inspection Services, USDA Donald J. Ereth Assistant Administrator for Research and Development Environmental Protection Agency John Moore Assistant Administrator for Pesticides and Toxic Substances Environmental Protection Agency James B. Wyngaarden Director, National Institutes of Health Frank Young Commissioner, Food and Drug Administration Counsel: John Cohrssen Consultant, Office of Science and Technology Policy, Executive Office of the President. Executive Secretary: Mary Martin Gant Policy Analyst, OSTP, Executive Office of the President.

888

List in Tolin Archive, Box #5, Folder: Legislation/BSCC.

390

Appendix H Jurisdiction for Federal Oversight of rDNA 8 8 9 Chart I - Coordinated Framework - Approval of Commercial Biotechnology Products (* indicates lead agency) Responsible Subject Agency(ies) Foods/Food Additives FDA* FSIS8 9 0 Human Drugs, Medical Devices and Biologics FDA Animal Drugs FDA Animal Biologics APHIS Other Contained Uses EPA Plants and Animals APHIS* FSIS FDA Pesticide Microorganisms Released in the Environment EPA* APHIS Other Uses (Microorganisms): (depends on whether organism is intergeneric, EPA intrageneric, or whether organism is a pathogen or for APHIS agricultural use) FDA

889

These charts are abbreviated from those published in the Coordinated Framework of June 26, 1986, which is at (51 FR 23302). The charts are on pp. 23304 and 23305. 890 FSIS is the Food Safety Inspection Service, in USDA Marketing and Inspection Division.

391 Chart II - Coordinated Framework - Biotechnology Research Jurisdiction (* indicates lead agency; others are secondary agencies)

Subject Contained Research, No Environmental Release 1.) Federally Funded 2.) Non-federally Funded

Foods/Food Additives, Drugs, Biologics, Med. Devices 1.) Federally Funded 2.) Non-federally Funded Plants, Animals, and Animal Biologics 1.) Federally Funded

2.) Non-federally Funded Pesticide Microorganisms (depends on whether organism is intergeneric, intrageneric, or whether organism is a pathogen or for agricultural use) Other Uses (Released Microorganisms) (depends on whether organism is intergeneric, intrageneric, or whether organism is a pathogen or for agricultural use, or whether federally or commercially funded)

891

Responsible Agency(ies) Funding Agency8 9 1 NIH or S&E voluntarily, or APHIS8 9 2 FDA*; NIH Guidelines FDA*; NIH voluntarily Funding Agency* APHIS APHIS; S&E voluntarily EPA,* APHIS; S&E (volunt.) Funding agency* EPA8 9 3 APHIS; S&E (volunt.)

Review and approval by FDA, NIH, or USDAÕs Science and Education division. For plant pests or shipment of regulated articles. 893 EPA reviews federally funded research only for commercial purposes or research on >10 acres. 892

Ass't Sec'y Food & Consumer Services

Food Safety & Inspection

"Regulatory Side"

Office of Grants & Programs Systems Dir. Ed. Kendrick

Ag. Research Service

"Research Side"

Compiled from the 1984 Yellow Book, Washington Monitor, Inc. Current as of December 6, 1983

Administered A-RAC

CSRS Admin. Pat Jordan Assoc. Adm. C. Harris

Soil Conserv.

Extension Service

Science & Education (SEA) Ass't Sec'y Orville Bentley

Undersec'y Internat'l Aff. & Commodities

Terry L. Medley Sr. Advisor

Office of General Counsel

Ass't Sec'y Administration

Forest Service

Ass't Sec'y Nat'l Resources & Environment

Plant Protect'n & Quarantine

Veterinary

APHIS Administrator Bert Hawkins

Marketing & Inspect. Ass't Sec'y C.W.McMillan Dep'ty Sec'y Karen Darling

Undersec'y Small Com. & Rural Devel.

Ass't Sec'y Economics

Secretary of Agriculture John Block

392

Appendix J

USDA 1984 Organizational Chart (Partial)

393

VITA NAME: Mary Ellen Jones ADDRESS: 808 Horseshoe Lane, Blacksburg, VA 24060

HOME PHONE: (540) 951-1213 E-mail: [email protected]

EDUCATION: Ph.D. - Science Studies Virginia Tech (Blacksburg, VA) 1999 Dissertation Title: Politically Corrected Science: The Early Negotiation of U.S. Agricultural Biotechnology Policy. Research directed by Dr. Doris T. Zallen. (540/231-4216). M.S. - Poultry Science University of Maryland (College Park, MD) 1 9 9 0 Thesis Title: DNA Fingerprinting Analysis of Behavioral Correlates of Mating Success and Non-Random Mating in Chickens. Research directed by Dr. Joy Mench (now at U.C., Davis). M.B.A. - Health Admin.

Loyola College (Baltimore, MD)

1986

B.S. - Biology

Towson State University (Baltimore, MD)

1977

AWARDS: Graduate Congressional Fellowship - July-December, 1997. Legislative aide for Congressman Rick Boucher (D-VA, 9th). Special emphasis on agriculture, biotechnology, science, seniors, welfare, and religion. The Virginia Governor's Fellowship - Summer, 1996. (Allen Admin.) Assistant policy analyst for biotechnology issues at the VA Dept. of Agriculture & Consumer Services. POSITIONS HELD: At Virginia Tech: Lab Technician Dr. Brenda Shirley 1995-1998 Molecular Biology 540/231-3013 Duties: Plasmid preps using Cesium Chloride gradient. Microbial culture; reagent prep. Also held Graduate Research Assistantships in Wood Sciences and Poultry Science, 1990-92. At University of Maryland: Graduate Teaching Assistant Dr. Wayne Kuenzel 1987-1990 Poultry Science - Genetics Duties: T.A. for Animal genetics and Ornithology lectures and laboratories. Data collection for population genetics in poultry. Avian blood sampling. Medical Employment: Montgomery Regional Hospital Ms. Suzanne Holiday 1991-1993 Blacksburg, VA Laboratory Manager Duties: Part-time medical technologist (H.E.W. and A.S.C.P. registered in hematology). Baltimore County General Dr. Simon Calle (now retired) 1977-1990 - Med. Tech. Hospital, Randallstown, MD 410/561-5940 1982-1987 - Lab Supervisor Duties: Supervisor for all emergency laboratories (blood bank, microbiology, hematology,etc.)